By Kurt R. Karst –
After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, issued a statement explaining his vote. A similar process may unfold in the U.S. House of Representatives as that chamber considers its version of a legislative package, H.R.5651, the Food and Drug Administration Reform Act of 2012. H.R. 5651 is ready for a floor vote, and House Republicans have indicated that they want to get a final bill to the President by July 4th. Late on May 24th, the Congressional Budget Office released a cost estimate of H.R. 5651. Both the Senate and House bills reauthorize old (PDUFA and MDUFA) and establish new (GDUFA and BsUFA) user fee statutes, and create several new provisions of law.
Over the past week, somewhere in the neighborhood of 40 amendments to S. 3187 were introduced in the Senate – see here, here, here, and here for the text of those amendments. That number was winnowed down to less than 20 amendments, which the Senate debated and voted on on Thursday, including votes on a couple of high-profile issues (e.g., reimportation and patent settlement agreements). Among other things, the Senate did not consider items such as an amendment from Sen. Orrin Hatch (R-UT) to repeal the medical device excise tax and generic drug labeling and preemption legislation. (The National Association of Attorneys General recently sent a letter to members of the Senate Judiciary Committee expressing support for the Patient Safety and Generic Labeling Improvement Act.)
Below is an overview of how the chips fell for each amendment considered and a brief summary of each amendment (except Senate Amendment No. 2122, a substitute version of S. 3187, which was agreed to by unanimous consent, and the text of which is available here).
Amendments Agreed To By Unanimous Consent Or Voice Vote
Amendment No. 2125 (Sen. Cardin) – Ensuring Adequate Information Regarding Pharmaceuticals For All Populations, Particularly Underrepresented Subpopulations, Including Racial Subgroups: The amendment would require FDA to “review and modify, as necessary, the [FDA’s] communication plan to inform and educate health care providers, patients, and payors on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.”
Amendment No. 2141 (Sen. Cardin) – Report On Small Business: FDA is required to submit a report to Congress (not later than one year after the date of enactment) that includes: “(1) a listing of and staffing levels of all small business offices at [FDA], including the small business liaison program; (2) the status of partnership efforts between [FDA] and the Small Business Administration; (3) a summary of outreach efforts to small businesses and small business associations, including availability of toll-free telephone help lines; (4) with respect to the program under the Orphan Drug Act (Public Law 97-414), the number of applications made by small businesses and number of applications approved for research grants, the amount of tax credits issued for clinical research, and the number of companies receiving protocol assistance for the development of drugs for rare diseases and disorders; (5) with respect to waivers and reductions for small business under [PDUFA], the number of small businesses applying for and receiving waivers and reductions from drug user fees . . . ; (6) the number of small businesses submitting applications and receiving approval for unsolicited grant applications from [FDA]; (7) the number of small businesses submitting applications and receiving approval for solicited grant applications from [FDA]; (8) barriers small businesses encounter in the drug and medical device approval process; and (9) recommendations for changes in the user fee structure to help alleviate generic drug shortages.”
Amendment No. 2121 (Sen. Grassley) – Protections For The Commissioned Corps Of The Public Health Service: This amendment offers whistleblower protections and prohibits retaliatory personnel actions.
Amendment No. 2129 (Sen. Grassley) – Regulations On Clinical Trial Registration; GAO Study Of Clinical Trial Registration And reporting Requirements: The amendment requires the issuance of a proposed rule on the registration of “applicable clinical trials” by “responsible parties” under PHS Act § 402(j) (as amended by § 801 of the FDA Amendments Act of 2007) not later than 180 days after the date of enactment, and the promulgation of a final rule not later than 180 days after the issuance of the proposed rule. Not later than two years after the issuance of the final rule, the Government Accountability Office (“GAO”) would be required to report on the rate of compliance and non-compliance of clinical trial registration, results reporting, and the completeness of reported data. If problems are found, then the GAO is to make recommendations for administrative or legislative actions to increase compliance.
Amendment No. 2151 (Sen. Manchin) – Hydrocodone Scheduling: The amendment reclassifies the scheduling of hydrocodone so that all drug products containing hydrocodone would be Schedule II controlled substances under the Controlled Substances Act. Although hydrocodone is currently a Schedule II controlled substance, when combined with certain other drugs it is in Schedule III.
Amendment No. 2126 (Sen. Reed) – Compliance Date For Rule Relating To Sunscreen Drug Products For OTC Human Use: The amendment states that “[i]n accordance with the final rule issued by the Commissioner of Food and Drug entitled ‘Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates’ (77 Fed. Reg. 27591 (May 11, 2012)), a product subject to the final rule issued by the Commissioner entitled ‘Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use’ (76 Fed. Reg. 35620 (June 17, 2011)), shall comply with such rule not later than – (1) December 17, 2013, for products subject to such rule with annual sales of less than $25,000 and (2) December 17, 2012, for all other products subject to such rule.” Senator Reed recently sent a letter to FDA expressing concern about the Agency's delay in putting sunscreen standards into effect. The delay was also criticized by the Environmental Working Group, which is seeking certain information from FDA on the issue.
Amendment No. 2142 (Sen. Leahy) – Freedom Of Information Act (“FOIA”): The amendment concerns the receipt and protection of confidential information obtained from foreign government agencies relating to drug inspections, and states that FDA shall not be required to disclose under FOIA (or any other provision of law) “any information relating to drug inspections obtained from a foreign government agency” if certain conditions are met.
Amendment No. 2145 (Sen. Portman) – Interstate Drug Monitoring Efficiency and Data Sharing Act of 2012: The Attorney General would be required to “establish national interoperability standards to facilitate the exchange of prescription information across State lines by States receiving grant funds” under the Harold Rogers Prescription Drug Monitoring Program and the Controlled Substance Monitoring Program not later than one year after the date of enactment.
Amendment No. 2131 (Sen. Coburn) – Independent Assessment Of The Drug And Biologic Application Review Process: The amendment requires FDA to “contract with a private, independent consulting firm capable of performing the technical analysis, management assessment, and program evaluation tasks required to conduct a comprehensive assessment of the process for the review of” applications under FDC Act § 505(b) and § 505(j) for drugs and PHS Act § 351(a) and § 351(k) for biologics. “The assessment shall address the premarket review process of drugs by [FDA], using an assessment framework that draws from appropriate quality system standards, including management responsibility, documents controls and records management, and corrective and preventive action.” Among other things, FDA would be required to “analyze the recommendations for improvement opportunities identified in the assessment, develop and implement a corrective action plan, and ensure its effectiveness.”
Amendment No. 2146 (Sen. Portman) – Synthetic Drug Abuse Prevention Act of 2012: This amendment would make certain “cannabimimetic agents” Schedule I controlled substances under the Controlled Substances Act.
Amendments Not Agreed To
Amendment No. 2111 (Sen. Bingaman); Not agreed to by a 28-67 vote – Ensuring That Valid Generic Drugs May Enter The Market: This amendment proposed to amend the FDC Act’s provisions with respect to “first applicant” status and 180-day marketing exclusivity for certain ANDA sponsors to address patent settlement agreements (or what opponents call “pay-for-delay” agreements).
Amendment No. 2108 (Sen. Murkowski); Not agreed to by a 46-50 vote – Analyses Of Application For Approval Of genetically-Engineered Fish: This amendment would have prevented FDA’s approval of any genetically modified marine or anadromous organism from taking effect until certain requirements are me.
Amendment No. 2107 (Sen. McCain); Not agreed to by a 43-54 vote – Safe And Affordable Drugs From Canada: The amendment would have required FDA to promulgate regulations permitting individuals to import into the United States a prescription drug (other than a controlled substance) that: “(1) is purchased from an approved Canadian pharmacy; (2) is dispensed by a pharmacist licensed to practice pharmacy and dispense prescription drugs in Canada; (3) is purchased for personal use by the individual, not for resale, in quantities that do not exceed a 90-day supply; (4) is filled using a valid prescription issued by a physician licensed to practice in the United States; and (5) has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved by [FDA].”
Amendment No. 2109 (Sen. Sanders); Not agreed to by a 9-88 vote – Conditions On Award Of Drug Exclusivity: The amendment proposed to terminate marketing exclusivity for drugs and biologics if the person to which such exclusivity was granted or any person to which such exclusivity is assigned commits certain violations or fails to report certain violations.
Amendment No. 2132 (Sen. Coburn) – FDA Employee Performance Awards: The amendment proposed to establish a system by which a portion of performance awards would be connected to the evaluation of the employee’s contribution to the goals under the various user fee agreements. The GAO recently issued a report concerning this topic, titled “Employee Performance Standards for the Timely Review of Medical Product Applications.”
Amendment No. 2130 (Sen. Burr) – Transparency In FDA User Fee Agreement Negotiations: The amendment would have added the following with respect to PDUFA, MDUFA, GDUFA, and BsUFA: “Notwithstanding any other provision of this section, Members of Congress or their designated staff may be present at any negotiation meeting conducted under this subsection between [FDA] and the regulated industry, if a Member of Congress decides to attend, or have his or her designated staff attend on his or her behalf. Any staff designated under the preceding sentence may be required to comply with applicable confidentiality agreements.”
Amendment No. 2143 (Sen. Paul); Tabled by a 78-15 vote – Dietary Supplements: Among other things, the amendment would have prohibited the Federal government from taking “any action to prevent use of a claim describing any nutrient in a food or dietary supplement . . . as mitigating, treating, or preventing any disease, disease symptom, or health-related condition, unless a Federal court in a final order following a trial on the merits finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that – (1) the claim is false and misleading in a material respect; and (2) there is no less speech restrictive alternative to claim suppression, such as use of disclaimers or qualifications, that can render the claim non-misleading.”
Amendment No. 2127 (Sen. Durbin); Tabled by a 77-20 vote – Registration Of Facilities With Respect To Dietary Supplements: The amendment proposed to require all dietary supplement facilities to register with FDA. Such registration would include: (1) a description of each dietary supplement product manufactured by such facility; (2) a list of all ingredients in each such dietary supplement product; and (3) a copy of the label and labeling for each such product. Failure to comply with registration requirements would result in misbranding of the products. Senator Durbin's statement on the amendment is available here.