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Drugs and Devices

Health Hippo: Drugs and Devices

Health Hippo: Drugs and Devices

US CODE || CFR || CASES || REPORTS || CONGRESSIONAL RECORD || BILLS || FEDERAL REGISTER


Extreme remedies are very appropriate for extreme diseases.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 is said to have produced the largest overhaul of Medicare in the program’s history. Title I of the Act created the Medicare Prescription Drug Benefit, while the other 9 titles “modernized” various other aspects of the Medicare program. Key provisions of Title I were the result of efforts from various lobbyist groups including AARP (subsidies for large employers designed to encourage them to keep prescription coverage for retirees) and drug companies (e.g., provisions preventing the government from negotiating discounts or establishing formularies). Costs of the program were substantially underestimated initially, but seem to have leveled off in the $500-600 billion range over a ten year period.

Part D drug coverage excludes drugs not approved by the Food and Drug Administration and drugs prescribed for off-label use, as well as drugs (usually injectables) that are already covered under Parts A or B of Medicare. Part D also excludes whole classes of drugs, including: weight loss/gain drugs; fertility drugs; erectile dysfunction drugs; cosmetic drugs; drugs that relieve cold symptoms, and; prescription vitamins (except prenatal). Barbiturates and benzodiazepines were excluded until January 2013. Part D plans can include excluded drugs as a supplemental benefit.

U.S. Code

  • Affordable Care Act: Prescription Drug Improvements
    • Sec. 3109. Exemption of certain pharmacies from accreditation requirements.
    • Sec. 3301. Medicare coverage gap discount program.
    • Sec. 3302. Improvement in determination of Medicare part D low-income benchmark premium.
    • Sec. 3303. Voluntary de minimis policy for subsidy eligible individuals under prescription drug plans and MA–PD plans.
    • Sec. 3304. Special rule for widows and widowers regarding eligibility for low-income assistance.
    • Sec. 3305. Improved information for subsidy eligible individuals reassigned to prescription drug plans and MA–PD plans.
    • Sec. 3306. Funding outreach and assistance for low-income programs.
    • Sec. 3307. Improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs.
    • Sec. 3308. Reducing part D premium subsidy for high-income beneficiaries.
    • Sec. 3309. Elimination of cost sharing for certain dual eligible individuals.
    • Sec. 3310. Reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA–PD plans.
    • Sec. 3311. Improved Medicare prescription drug plan and MA–PD plan complaint system.
    • Sec. 3312. Uniform exceptions and appeals process for prescription drug plans and MA–PD plans.
    • Sec. 3313. Office of the Inspector General studies and reports.
    • Sec. 3314. Including costs incurred by AIDS drug assistance programs and Indian Health Service toward the annual out-of-pocket threshold under part D.
    • Sec. 3315. Immediate reduction in coverage gap in 2010.
    • Sec. 3503. Medication management services in treatment of chronic disease.
    • Sec. 3507. Presentation of prescription drug benefit and risk information.
    • Sec. 6004. Prescription drug sample transparency.
    • Sec. 6005. Pharmacy benefit managers transparency requirements.
    • Sec. 7101. Expanded participation in 340B program.
    • Sec. 7102. Improvements to 340B program integrity.
    • Sec. 7103. GAO study to make recommendations on improving the 340B program.
    • Sec. 10328. Improvement in part D medication therapy management (MTM) programs.
    • Sec. 10409. Cures Acceleration Network.
    • Sec. 10609. Labeling changes.

Code of Federal
Regulations

  • 21 CFR CHAPTER I FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    • SUBCHAPTER A General (Parts 1 to 99)
    • SUBCHAPTER C Drugs: General (Parts 200 to 299)
      • Part 200 General (200.5 – 200.200)
      • Part 201 Labeling (201.1 – 201.327)
      • Part 202 Prescription Drug Advertising (202.1 – 202.1)
      • Part 203 Prescription Drug Marketing (203.1 – 203.70)
      • Part 205 Guidelines for State Licensing of Wholesale Prescription Drug Distributors (205.1 – 205.50)
      • Part 206 Imprinting of Solid Oral Dosage Form Drug Products for Human Use (206.1 – 206.10)
      • Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (207.3 – 207.40)
      • Part 208 Medication Guides for Prescription Drug Products (208.1 – 208.26)
      • Part 209 Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement (209.1 – 209.11)
      • Part 210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General (210.1 – 210.3)
      • Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (211.1 – 211.208)
      • Part 212 Current Good Manufacturing Practice for Positron Emission Tomography Drugs (212.1 – 212.110)
      • Part 216 Pharmacy Compounding (216.23 – 216.24)
      • Part 225 Current Good Manufacturing Practice for Medicated Feeds (225.1 – 225.202)
      • Part 226 Current Good Manufacturing Practice for Type A Medicated Articles (226.1 – 226.115)
      • Part 250 Special Requirements for Specific Human Drugs (250.11 – 250.250)
      • Part 290 Controlled Drugs (290.1 – 290.10)
      • Part 299 Drugs; Official Names and Established Names (299.3 – 299.5)
    • SUBCHAPTER D Drugs For Human Use (Parts 300 to 370)
      • Part 300 General (300.50 – 300.100)
      • Part 310 New Drugs (310.3 – 310.548)
      • Part 312 Investigational New Drug Application (312.1 – 312.320)
      • Part 314 Applications for FDA Approval to Market a New Drug (314.1 – 314.650)
      • Part 315 Diagnostic Radiopharmaceuticals (315.1 – 315.6)
      • Part 316 Orphan Drugs (316.1 – 316.52)
      • Part 320 Bioavailability and Bioequivalence Requirements (320.1 – 320.63)
      • Part 328 Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol (328.1 – 328.50)
      • Part 330 Over-the-Counter (OTC) Human Drugs Which Are Generally Recognized as Safe and Effective and Not Misbranded (330.1 – 330.14)
      • Part 331 Antacid Products for Over-the-Counter (OTC) Human Use (331.1 – 331.80)
      • Part 332 Antiflatulent Products for Over-the-Counter Human Use (332.1 – 332.31)
      • Part 333 Topical Antimicrobial Drug Products for Over-the-Counter Human Use (333.101 – 333.350)
      • Part 335 Antidiarrheal Drug Products for Over-the-Counter Human Use (335.1 – 335.50)
      • Part 336 Antiemetic Drug Products for Over-the-Counter Human Use (336.1 – 336.80)
      • Part 338 Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use (338.1 – 338.50)
      • Part 340 Stimulant Drug Products for Over-the-Counter Human Use (340.1 – 340.50)
      • Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (341.1 – 341.90)
      • Part 343 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (343.1 – 343.90)
      • Part 344 Topical Otic Drug Products for Over-the-Counter Human Use (344.1 – 344.52)
      • Part 346 Anorectal Drug Products for Over-the-Counter Human Use (346.1 – 346.52)
      • Part 347 Skin Protectant Drug Products for Over-the-Counter Human Use (347.1 – 347.60)
      • Part 348 External Analgesic Drug Products for Over-the-Counter Human Use (348.1 – 348.50)
      • Part 349 Ophthalmic Drug Products for Over-the-Counter Human Use (349.1 – 349.80)
      • Part 350 Antiperspirant Drug Products for Over-the-Counter Human Use (350.1 – 350.60)
      • Part 352 Sunscreen Drug Products for Over-the-Counter Human Use [Stayed Indefinitely] (352.1 – 352.77)
      • Part 355 Anticaries Drug Products for Over-the-Counter Human Use (355.1 – 355.70)
      • Part 357 Miscellaneous Internal Drug Products for Over-the-Counter Human Use (357.101 – 357.850)
      • Part 358 Miscellaneous External Drug Products for Over-the-Counter Human Use (358.101 – 358.760)
      • Part 361 Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used In Research (361.1 – 361.1)
      • Part 369 Interpretative Statements Re Warnings On Drugs and Devices for Over-the-Counter Sale (369.1 – 369.21)
    • SUBCHAPTER H Medical Devices (Parts 800 to 898)
      • Part 800 General (800.10 – 800.55)
      • Part 801 Labeling (801.1 – 801.437)
      • Part 803 Medical Device Reporting (803.1 – 803.58)
      • Part 806 Medical Devices; Reports Of Corrections and Removals (806.1 – 806.40)
      • Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers Of Devices (807.3 – 807.100)
      • Part 808 Exemptions From Federal Preemption Of State and Local Medical Device Requirements (808.1 – 808.101)
      • Part 809 In Vitro Diagnostic Products for Human Use (809.3 – 809.40)
      • Part 810 Medical Device Recall Authority (810.1 – 810.18)
      • Part 812 Investigational Device Exemptions (812.1 – 812.150)
      • Part 813 [Reserved]
      • Part 814 Premarket Approval Of Medical Devices (814.1 – 814.126)
      • Part 820 Quality System Regulation (820.1 – 820.250)
      • Part 821 Medical Device Tracking Requirements (821.1 – 821.60)
      • Part 822 Postmarket Surveillance (822.1 – 822.38)
      • Part 860 Medical Device Classification Procedures (860.1 – 860.136)
      • Part 861 Procedures for Performance Standards Development (861.1 – 861.38)
      • Part 862 Clinical Chemistry and Clinical Toxicology Devices (862.1 – 862.3950)
      • Part 864 Hematology and Pathology Devices (864.1 – 864.9900)
      • Part 866 Immunology and Microbiology Devices (866.1 – 866.6050)
      • Part 868 Anesthesiology Devices (868.1 – 868.6885)
      • Part 870 Cardiovascular Devices (870.1 – 870.5925)
      • Part 872 Dental Devices (872.1 – 872.6890)
      • Part 874 Ear, Nose, and Throat Devices (874.1 – 874.5840)
      • Part 876 Gastroenterology-Urology Devices (876.1 – 876.5990)
      • Part 878 General and Plastic Surgery Devices (878.1 – 878.5910)
      • Part 880 General Hospital and Personal Use Devices (880.1 – 880.6992)
      • Part 882 Neurological Devices (882.1 – 882.5975)
      • Part 884 Obstetrical and Gynecological Devices (884.1 – 884.6200)
      • Part 886 Ophthalmic Devices (886.1 – 886.5933)
      • Part 888 Orthopedic Devices (888.1 – 888.5980)
      • Part 890 Physical Medicine Devices (890.1 – 890.5975)
      • Part 892 Radiology Devices (892.1 – 892.6500)
      • Part 895 Banned Devices (895.1 – 895.101)
      • Part 898 Performance Standard for Electrode Lead Wires and Patient Cables (898.11 – 898.14)
  • 42 CFR PART 423 VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT (423.1 – 423.2345)
    • SUBPART A General Provisions (423.1 – 423.6)
    • SUBPART B Eligibility and Enrollment (423.30 – 423.56)
    • SUBPART C Benefits and Beneficiary Protections (423.100 – 423.136)
    • SUBPART D Cost Control and Quality Improvement Requirements (423.150 – 423.171)
    • SUBPART E [Reserved]
    • SUBPART F Submission of Bids and Monthly Beneficiary Premiums; Plan Approval (423.251 – 423.293)
    • SUBPART G Payments to Part D Plan Sponsors for Qualified Prescription Drug Coverage (423.301 – 423.350)
    • SUBPART H [Reserved]
    • SUBPART I Organization Compliance with State Law and Preemption by Federal Law (423.401 – 423.440)
    • SUBPART J Coordination of Part D Plans With Other Prescription Drug Coverage (423.452 – 423.466)
    • SUBPART K Application Procedures and Contracts with Part D plan sponsors (423.500 – 423.520)
    • SUBPART L Effect of Change of Ownership or Leasing of Facilities During Term of Contract (423.551 – 423.553)
    • SUBPART M Grievances, Coverage Determinations, Redeterminations, and Reconsiderations (423.558 – 423.638)
    • SUBPART N Medicare Contract Determinations and Appeals (423.641 – 423.668)
    • SUBPART O Intermediate Sanctions (423.750 – 423.764)
      • Sec. 423.750 Types of intermediate sanctions and civil money penalties.
      • Sec. 423.752 Basis for imposing intermediate sanctions and civil money penalties.
      • Sec. 423.756 Procedures for imposing intermediate sanctions and civil money penalties.
      • Sec. 423.758 Collection of civil money penalties imposed by CMS.
      • Sec. 423.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
      • Sec. 423.762 Settlement of penalties.
      • Sec. 423.764 Other applicable provisions.
    • SUBPART P Premiums and Cost-Sharing Subsidies for Low-Income Individuals (423.771 – 423.800)
    • SUBPART Q Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug Plans) (423.851 – 423.875)
    • SUBPART R Payments to Sponsors of Retiree Prescription Drug Plans (423.880 – 423.894)
    • SUBPART S Special Rules for States-Eligibility Determinations for Subsidies and General Payment Provisions (423.900 – 423.910)
    • SUBPART T Appeal Procedures for Civil Money Penalties (423.1000 – 423.1094)
    • SUBPART U Reopening, ALJ Hearings, MAC review, and Judicial Review (423.1968 – 423.2140)
    • SUBPART V Part D Marketing Requirements (423.2260 – 423.2276)
    • SUBPART W Medicare Coverage Gap Discount Program (423.2300 – 423.2345)

Cases

  • Warning Letters and Notice of Violation Letters to Pharmaceutical Companies (1997 – present) From the Office of Prescription Drug Promotion. Some of the letters have been redacted or edited to remove confidential information. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.
  • Advisory Opinion 14-06 (OIG 2014) (specialty pharmacy’s proposal to pay local retail pharmacies a fee for support services they provide in connection with patient referrals could potentially generate prohibited remuneration under the anti-kickback statute)
  • Advisory Opinion 14-05 (OIG 2014) (pharmaceutical manufacturer’s direct-to-patient product sales program that allows eligible patients to purchase one of the manufacturer’s brand-name products for a fixed cash price from an online retail pharmacy vendor outside of any applicable prescription drug insurance benefit would not result in the imposition of sanctions)
  • In the Case of J.R. (MAC 2013) (no authority to grant a tiering exception for the enrollees modafinil under the facts of this case).
  • In the Case of J.S. (MAC 2012) (enrollee did not establish that he qualifies for a formulary exception because there is no evidence that each of the formulary drugs is either ineffective or contraindicated).
  • In the Case of K.M. (MAC 2012) (contrary to the ALJ’s finding, and based on the medical records and supporting statements from the beneficiary’s treating physician, the drug prescribed was not for an off-label use).
  • In the Case of R.S. (MAC 2011) (Appeals Council is bound to follow the Secretary’s implementing regulations and the enrollee’s use of the prescribed drug is not for a “medically accepted indication”).
  • In the Case of E.D. (MAC 2011) (under the terms of the Evidence of Coverage, the Part D Plan is responsible for paying at least a portion of the cost of the drug Thalomid dispensed to the enrollee during the initial coverage period and the catastrophic coverage period).
  • In the Case of S.A.B. (MAC 2009) (because the drug prescribed for the enrollee’s autoimmune conditions is for an off-label use and is not supported in a compendia for treatment of any of the conditions with which the enrollee is diagnosed, it is not a covered Medicare Part D drug).
  • In the Case of V.B.M. (MAC 2009) (the prescribed drug qualifies for a exception and is eligible for Part D coverage as compendia recognized as an authoritative source for determining coverage status of prescription drugs includes the prescribed drug as a grandfathered drug that was marketed for the prescribed use prior to the enactment of the Federal Food, Drug and Cosmetic Act of 1938 and therefore has technically never been “approved” by the Food and Drug Administration).
  • Medtronic v. Lohr (U.S. 1996)(1978 Medical Device Ammendments do not preempt state lawsuits alleging design defects).
  • Benedi V. McNeil (4th Cir. 1995) (upholding $8 million award for liver damage caused by mixing alcohol with Tylenol).

Reports

  • Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals (OIG 2015) Traditionally, pharmacies compounded a drug upon receipt of a prescription for an individual patient. However, recent trends in drug compounding have included the large-scale production of certain drugs by standalone compounding pharmacies to meet the needs of some hospitals.
  • Compounded Drugs: Payment Practices Vary across Public Programs and Private Insurers, and Medicare Part B Policy Should Be Clarified (GAO 2014) The Centers for Medicare & Medicaid Services (CMS), the agency within the Department of Health and Human Services (HHS) responsible for administering the Medicare program, has a national payment policy for compounded drugs under Medicare Part B, but this policy is unclear. The policy generally states that drugs must be FDA-approved to be paid for under Medicare. Payment may be available for compounded drugs, but the policy does not stipulate whether payment is available for ingredients that are bulk drug substances, which are generally not FDA-approved.
  • Special Advisory Bulletin: Pharmaceutical Manufacturer Copayment Coupons (OIG 2014) Pharmaceutical manufacturers offer copayment coupons to insured patients to reduce or eliminate the cost of their out-of-pocket copayments for specific brand-name drugs. When the item in question is one for which payment may be made, in whole or in part, under a Federal health care program (including Medicare Part D), the anti-kickback statute is implicated.
  • Annual Fee on Branded Prescription Drug Companies Under the Affordable Care Act (OIG 2014) This memorandum provides information about funds received by the Federal Supplementary Medical Insurance (Medicare Part B) Trust Fund (hereinafter referred to as the Trust Fund) through the annual fee on branded prescription drug companies, pursuant to section 9008 of the Affordable Care Act (ACA), P.L. lll-148.
  • HRSA Office of Pharmacy Affairs: 340B Drug Pricing Program The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices stretching scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.
  • Interpretive Rule: Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program The purpose of this document is to describe the manner in which section 340B(e) of the PHSA will be interpreted and implemented by HHS. The effective date is July 21, 2014.
  • Prescription Drugs: Comparison of DOD, Medicaid, and Medicare Part D Retail Reimbursement Prices (GAO 2014) Medicaid paid the lowest average net prices across a sample of 78 high-utilization and high-expenditure brand-name and generic drugs when compared to prices paid by the Department of Defense (DOD) and Medicare Part D. Similarly, Medicaid paid the lowest net price for the subset of brand-name drugs in the sample, while DOD paid 34 percent more and Medicare Part D paid an estimated 69 percent more. Medicaid also paid the lowest net price for the subset of generic drugs, while Medicare Part D paid 4 percent more and DOD paid 50 percent more.
  • Prescription Drug Coverage Contracting Detailed information on PDP application/renewal requirements, marketing guidelines, formulary requirements, coordination of benefits, plan reporting and oversight, and other special guidance.
  • Drugs@FDA Search for your drug’s label to determine if it is being prescribed for an approved indication, which determines Medicare and Medicaid drug plan responsibility for coverage. If your particular use of the drug is not listed as a label indication it may possibly be covered for off-label use, but the compendia that collect this information are not currently available for free searching.
  • Drug Approvals and Databases Includes FDA databases for: Acronyms and Abbreviations, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), Bioresearch Monitoring Information System (BMIS), Clinical Investigator Inspection List (CLIIL), Dissolution Methods Database, Drug Establishments Current Registration Site, Drugs@FDA, FDA Adverse Event Reporting System (FAERS) Quarterly Data Files, Inactive Ingredient Search for Approved Drug Products, National Drug Code Directory, Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) and Postmarket Requirements and Commitments.
  • MedPac: Part D Databook Characteristics of Part D enrollees in 2007.
  • MedPac: Part D Payment System In 2006, Medicare began a voluntary outpatient drug benefit known as Part D. A combination of stand-alone prescription drug plans (PDPs) and Medicare Advantage (MA)-Prescription Drug plans (MA-PDs) delivers the benefit. In each of 34 geographic regions, plans compete for enrollees on the basis of annual premiums, benefit structures, specific drug therapies covered, pharmacy networks, and quality of services.
  • Drug Compendia Publishers Maintain Transparent Processes for Evaluating Anticancer Drug Therapies and Identifying Potential Conflicts (OIG 2014) Medicare Parts Band D cover anticancer drugs for indications not approved by the Food and Drug Administration (FDA) only ifthe drugs are supported by one or more of the four authorizedcompendia. Conflictsofinterestonthepartofcompendiastaffmightresultin anticancer drugs being included in the compendia that otherwise might not have been included.
  • Internet Pharmacies: Most Rogue Sites Operate from Abroad, and Many Sell Counterfeit Drugs (GAO 2014) NABP’s recent analysis shows that 97 percent of the over 10,000 Internet pharmacies that it reviewed were out of compliance with laws or industry standards. Some rogue sites seek to assure consumers of the safety of their drugs by purporting to be Canadian despite being located elsewhere or selling drugs sourced from other countries.
  • Memorandum Report: Contract Pharmacy Arrangements in the 340B Program (OIG 2014) This memorandum report describes selected covered entities’ contract pharmacy arrangements and their oversight of those arrangements to prevent (1) diversion of drugs purchased through the 340B Drug Pricing Program to ineligible patients and (2) duplicate discounts through Medicaid.
  • Medicare Inappropriately Paid for Drugs Ordered by Individuals Without Prescribing Authority (OIG 2013) Nationwide, Part D inappropriately paid for drugs ordered by individuals who clearly did not have the authority to prescribe, such as massage therapists, athletic trainers, home contractors, interpreters, and transportation companies. podcast
  • Regulation of Prescription Drug Promotion (FDA 2013) Training materials provided by the Office of Prescription Drug Promotion related to regulatory authority over drug advertising.
  • Prescription Drugs: Comparison of DOD and VA Direct Purchase Prices (GAO 2013) When GAO compared prices paid by the Department of Defense (DOD) and the Department of Veterans Affairs (VA) for a sample of 83 drugs purchased in the first calendar quarter of 2012, DOD’s average unit price for the entire sample was 31.8 percent ($0.11 per unit) higher than VA’s average price, and DOD’s average unit price for the subset of 40 generic drugs was 66.6 percent ($0.04 per unit) higher than VA’s average price.
  • Drug Compounding: Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight (GAO 2013) The authority of the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to oversee drug compounding is unclear. Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country.
  • The Number, Role, and Ownership of Pharmacy Services Administrative Organizations (GAO 2013) The majority of PSAOs in operation in 2011 or 2012 were owned by drug wholesalers and independent pharmacy cooperatives. Of the 22 PSAOs we identified, 9 PSAOs were owned by wholesalers, 6 were owned by independent pharmacy cooperatives, 4 were owned by group purchasing organizations, and 3 were stand-alone PSAOs owned by other private entities.
  • Gaps in Oversight of Conflicts of Interest in Medicare Prescription Drug Decisions (OIG 2013) Federal law and regulations require Medicare Part D Pharmacy and Therapeutics (P&T) committees to make prescription drug coverage decisions based on scientific evidence and standards of practice. Formulary decisions affect beneficiaries’ access to specific prescription drugs and the cost of drugs to beneficiaries and the Federal Government. To comply with the law, sponsors’ committees must prevent conflicts of interest from influencing members to give preference to certain drugs.
  • Antibiotics: FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information (GAO 2012) FDA designates certain drugs as reference-listed drugs and the sponsors of these drugs play an important role in ensuring the accuracy of drug labels. Reference-listed drugs are approved drug products to which generic versions are compared. FDA has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints.
  • FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information (GAO 2012) FDA has not taken sufficient steps to ensure that antibiotic labels contain up-to-date breakpoints.
  • States Collection of Medicaid Rebates for Drugs Paid Through Medicaid Managed Care Organizations (OIG 2012) Drugs dispensed by Medicaid Managed Care Organizations (MCO) were excluded from this requirement until March 23, 2010, when section 2501(c) of the Patient Protection and Affordable Care Act (ACA) expanded the rebate requirement to include these drugs. To realize the full savings under this expansion, it is important that States collect accurate drug utilization data from MCOs and that States invoice and collect rebate payments from manufacturers.
  • Trends in Usual and Customary Prices for Commonly Used Drugs (GAO 2011) GAO found that the U&C price index for our first basket of 100 commonly used prescription drugs increased at an average annual rate of 6.6 percent from 2006 through the first quarter of 2010 compared with a 3.8 percent average annual increase in the consumer price index for medical goods and services (medical CPI).
  • Drug Shortages: FDA’s Ability to Respond Should Be Strengthened (GAO 2011) The number of drug shortages has grown substantially since 2006. In total, 1,190 shortages were reported from January 1, 2001, through June 20, 2011, according to UUDIS data.
  • FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain (GAO 2011) Inspections of foreign drug manufacturers are an important element of FDA’s oversight of the supply chain, but GAO’s prior work showed that FDA conducts relatively few such inspections.
  • Manufacturer Discounts in the 340B Program Offer Benefits, but Federal Oversight Needs Improvement (GAO 2011) Thirteen of 29 covered entities reported that they generated 340B program revenue that exceeded drug-related costs, which includes the costs of purchasing and dispensing drugs. Of those remaining, 10 did not generate enough revenue to exceed drug-related costs, and 6 did not report enough information to determine the extent to which revenue was generated.
  • Concerns With Rebates in the Medicare Part D Program (OIG 2011) Because of the size of these rebates, it is vital that rebates be reported accurately and that the Government and beneficiaries receive the full benefit of these rebates. Our review identified several concerns about these rebates.
  • Replacing Average Wholesale Price: Medicaid Drug Payment Policy (OIG 2011) Federal regulations require, with certain exceptions, that Medicaid reimbursement amounts for prescription drugs not exceed (in the aggregate) the lower of (1) the estimated acquisition cost plus a dispensing fee or (2) the providers usual and customary charge to the public for the drug.
  • Overview of Approaches to Control Prescription Drug Spending in Federal Programs (GAO 2009) Millions of individuals receive prescription drugs through federal programs. The increasing cost of prescription drugs has put pressure to control drug spending on federal programs such as the Federal Employees Health Benefits Program (FEHBP), Medicare Part D, the Department of Veterans Affairs (VA), the Department of Defense (DOD), and Medicaid.
  • FDA’s Oversight of the Promotion of Drugs for Off-Label Uses (GAO 2008) GAO reviewed (1) how FDA oversees the promotion of off-label uses of prescription drugs and (2) what actions have been taken to address off-label promotions. GAO examined documentation related to the promotion of drugs for off-label uses and FDA correspondence with drug companies on identified violations and obtained information from DOJ on relevant actions. GAO also interviewed officials at FDA and the HHS Office of Inspector General and representatives of national medical and pharmaceutical associations.
  • The Orphan Drug Act: Implementation and Impact (OIG 2001) Congress passed the Orphan Drug Act of 1983 to stimulate the development of drugs for rare diseases. A rare disease is defined as a disease that affects fewer than 200,000 people in the United States. Prior to passage of this historic legislation, private industry had little incentive to invest money in the development of treatments for small patient populations, because the drugs were expected to be unprofitable. The law provides 7-year marketing exclusivity to sponsors of approved orphan products, a tax credit of 50 percent of the cost of conducting human clinical testing, and research grants for clinical testing of new therapies to treat orphan diseases. Exclusive marketing rights limit competition by preventing other companies from marketing the same version of the drug, unless they can prove clinical superiority.
  • FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO 1995) Pursuant to a congressional request, GAO provided data on the Food and Drug Administration’s (FDA) new drug application (NDA) process.
  • Prescription Drugs: Implications of Drug Labeling and Off-Label Use (GAO 1996) The extent of off-label drug use has not been documented, but there is evidence that off-label use is common among cancer, acquired immunodeficiency syndrome, and pediatric populations. The drug industry feels overly constrained by labels in its ability to promote pharmaceutical products. Physicians can use approved drugs for conditions or patients other than those listed on the drugs’ labels, but manufacturers cannot advertise or promote such use.
  • Medicaid: Changes in Best Price for Outpatient Drugs Purchased by HMOs and Hospitals (GAO 1994) Congress has tried to reduce Medicaid prescription drug costs by requiring drug manufacturers to give state Medicaid programs rebates for outpatient drugs.
  • Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated (GAO 1995) GAO reviewed the creation of a drug class that would be available only through pharmacies, but would not require a physician’s prescription.
  • Pharmacy Benefit Managers: Early Results on Ventures with Drug Manufacturers (GAO 1995) GAO reviewed mergers between pharmacy benefit managers (PBM) and pharmaceutical manufacturers.
  • FDA Drug Approval: Review Time Has Decreased in Recent Years (GAO 1995) Pursuant to a congressional request, GAO provided data on the Food and Drug Administration’s (FDA) new drug application (NDA) process.
  • Prescription Drugs and the Elderly: Many Still Receive Potentially Harmful Drugs Despite Recent Improvements (GAO 1995) Pursuant to a congressional request, GAO examined the elderly’s inappropriate use of prescription drugs.
  • Cholesterol Treatment: A Review of the Clinical Trials Evidence (GAO 1996) Pursuant to a congressional request, GAO reviewed the evidence from clinical trials that the National Heart, Lung, and Blood Institute (NHLBI) used to develop its National Cholesterol Education Program guidelines.
  • Tax Policy: Pharmaceutical Industry’s Use of the Research Tax Credit (GAO 1994) In 1991, Congress enacted the research and experimentation tax credit to encourage businesses to do research. GAO estimates that the pharmaceutical industry earned $1.24 billion worth of these tax credits between 1981 and 1990.
  • Prescription Drugs: Automated Prospective Review Systems Offer Significant Potential Benefits for Medicaid (GAO 1994) Use of automatic systems linked to statewide databases could provide a more thorough prospective review than reviews based on manual or local systems.
  • Prescription Drugs: Spending Controls in Four European Countries (GAO 1994) Although the United States has traditionally allowed drug prices to be determined by the free market, other countries use a variety of policies to control prescription drug costs.
  • Implementing User Fees in the Food and Drug Administration: A Case Study (OIG 1990) The HHS currently charges user fees for a variety of purposes. Additional fees will become effective soon, induding user charges to States (who are expected to recover the charge from end users) for using the Federal Parent Locator Servce in certain cases, and user charges to laboratories conducting medical testing to recoup the cost of regulating those laboratories under the Clinical Laboratories Improvement Amendments of 1988 (CLIA).

Devices

  • Special Fraud Alert: Physician-Owned Entities (OIG 2013) OIG addresses physician-owned entities that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers.
  • FDA Should Expand Its Consideration of Information Security for Certain Types of Devices (GAO 2012) Several information security threats exist that can exploit vulnerabilities in active implantable medical devices, but experts caution that efforts to mitigate information security risks may adversely affect device performance.
  • Scientific Disagreements Regarding Medical Device Regulatory Decisions (OIG 2012) At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions.
  • Medical Devices: FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer (GAO 2012) Even though FDA met all medical device performance goals for 510(k)s, the elapsed time from submission to final decision has increased substantially in recent years. This time to final decision includes the days FDA spends reviewing a submission as well as the days FDA spends waiting for a device sponsor to submit additional information in response to a request by the agency.
  • FDA Should Enhance Its Oversight of Recalls (GAO 2011) From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. FDA classified the vast majority–nearly 83 percent–as class II, meaning use of these recalled devices carried a moderate health risk, or that the probability of serious adverse health consequences was remote.
  • FDA’s Premarket Review and Postmarket Safety Efforts (GAO 2011) GAO has identified a wide variety of concerns related to FDA’s ability to fulfill its mission of protecting the public health and added FDA’s oversight of medical products, including devices, to its list of high-risk areas.
  • Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process (GAO 2009) Certain types of class III devices that were in commercial distribution in the United States before May 28, 19766 (called preamendment device types) and those determined to be substantially equivalent to them may be cleared through the less stringent 510(k) process until FDA publishes regulations requiring them to go through the PMA process or reclassifies them into a lower class.
  • Medical Devices: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments (GAO 2009) Recently, concerns have been expressed about FDAs ongoing ability to fulfill its mission of ensuring the safety and efficacy of medical products, including drugs, biologics, and devices. Reports issued by FDAs Science Board in 2007 and the Congressional Research Service in 2008 point out that the demands on the agency have soared in recent years for a variety of reasons, including the complexity of new products submitted to FDA for premarket approval and the globalization of the industries that FDA regulates. The Science Board also found that FDAs resources had not increased in proportion to the growing demands placed on it, putting public health at risk.
  • FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments (GAO 2008) FDA has not met the statutory requirement to inspect certain domestic establishments manufacturing medical devices every 2 years, and the agency faces challenges inspecting foreign establishments.
  • Medical Devices: FDA’s Approval of Four Temporomandibular Joint Implants (GAO 2007) FDA officials raised concerns during the approval process that were similar for all four TMJ implants. These concerns generally involved the adequacy of the sponsors clinical study protocols, patient follow-up, engineering testing, and other matters, such as device labeling.
  • Medical Devices: Reprocessing and Reuse of Devices Labeled Single-Use (GAO 2000) Manufacturers that wish to market a device for single use need to convince FDA only that it can be used safely and effectively oncethey do not need to demonstrate that the device cannot be used more than once. Thus, FDAs approval of a device for single use means that a device can be used safely and reliably once, not necessarily that it cannot be used safely and reliably more than once if it is appropriately reprocessed.
  • Medical Devices: European Union’s Regulatory Process (GAO 1997) Critics claim that regulatory mechanisms under the European Unions (EU) system are more efficient, and thus faster, and have suggested that elements of the EU approach be adopted as part of a more general reform of FDA. In order to more fully understand the nature of the comparisons being made between the FDA and EU approaches, you requested that we examine the EU system of regulating the entry of medical devices into the marketplace, with a specific focus on product review time.
  • Medical Devices: FDA Review Time (GAO 1995) Pursuant to a congressional request, GAO reviewed the Food and Drug Administration’s (FDA) review of medical devices, focusing on how FDA review time has changed from fiscal year 1989 to May 18, 1995.
  • Medicare: Technology Assessment and Medical Coverage Decisions (GAO 1994) Thousands of medical procedures, devices, and drugs are available for patient care in this country. Each year, public and private health care insurers make coverage decisions for these medical technologies.
  • Medical Device Regulation: Too Early to Assess European System’s Value as Model for FDA (GAO 1996) Pursuant to a congressional request, GAO compared the Food and Drug Administration’s (FDA) and the European Union’s (EU) systems for reviewing and approving medical devices.
  • Medical Device Reporting: Improvements Needed in FDA’s System for Monitoring Problems With Approved Devices (GAO 1997) Pursuant to a legislative requirement, GAO reviewed user facilities’ compliance with the Safe Medical Devices Act of 1990’s (SMDA 90) reporting requirements.
  • Investigational Devices: Four Case Studies (OIG 1995) Whether controls over clinical testing of investigational devices ensure patient safety and sound clinical research. Four case studies to develop a picture of clinical trials for investigational medical devices, with each device’s manufacturer, selected clinical investigators and IRB representatives interviewed.
  • Medical Devices: FDA’s Implementation of the Medical Device Reporting Regulation (GAO 1989) The amount of information received by FDA about problems associated with medical devices has increased more than seven-fold since the implementation of the MDR regulation. However, the system of organizational structures and procedures that FDA uses to process and analyze MDR reports was grafted onto the one that was designed for the voluntary problem-reporting that existed before MDR. The resulting system is not adequate to handle the volume of reports currently received.
  • Medical Devices: The Public Health at Risk (GAO 1989) More than 1,700 different types of medical devices are available in the United States today, millions of Americans come into contact with them, and these devices represent an industry of more than $14 billion annually.
  • Medical Devices: FDA’s 510(k) Operations Could Be Improved (GAO 1998) Concerned about the extensive use of premarket notification as compared to premarket approval, the Subcommittee on Health and the Environment of the House Committee on Energy and Commerce asked the General Accounting Office (GAO) to review FDA’S implementation of premarket notification in terms of both formal policies and day-to-day operations. GAO was also asked to iden- tify any problems pertaining to premarket notification resulting from implementation of other provisions of the amendments.

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