Among the lingering questions for FDA supporters coming out of the Memorial Day holiday may be whether the House can continue the relatively swift approval of the user fee package.

The Senate passed its user fee bill, the FDA Safety and Innovation Act, by a 96-1 vote on May 24 in a mostly smooth floor debate. It approved 10 amendments, in addition to the manager's floor amendment, which made some minor changes (see chart).

While the bill includes language creating federal track-and-trace standards for drug shipments, Senate leaders indicated it was only a placeholder and that the issue likely would not be addressed until the conference committee.

Industry avoided two potentially big problems with the bill. Amendments that would have allowed consumers to purchase drugs from Canadian pharmacies and essentially ban pay-for-delay generic settlements failed. FDA also appeared to dodge any major mandates during the Senate amendment process. Most of the adjustments required speedier rulemaking or required reports and studies.

House members are expected to vote on their bill, the FDA Reform Act, on May 30. They already were forced to make changes because the Congressional Budget Office said it would increase the budget deficit $247 million between fiscal years 2013 and 2022. A manager’s amendment to address the problem was filed May 25 Also see "PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS" - Pink Sheet, 28 May, 2012..

The House bill still raises some contentious issues, however. While FDA mission statement changes were removed, no track-and-trace system has been added yet. A potentially burdensome provision requiring public participation in the guidance development process also remains Also see "User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop" - Pink Sheet, 30 April, 2012..

House members also disagreed during the mark-up about the extent of antibiotic incentives included in the bill. Energy and Commerce Committee Ranking Member Henry Waxman, D-Calif., said the incentive should be more targeted ([A#00120514019]). It could precipitate an effort to insert the Limited Population Antibacterial Drug mechanism into the bill, which would allow faster approval of antibiotics affecting limited populations and treating highly-resistant bacteria Also see "Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain" - Pink Sheet, 19 April, 2012..

Those differences could create more challenges for the conference committee. Senate leaders seem to be hoping most of those meetings can be reserved for finishing a track-and-trace deal ([A#14120522008]). Consensus seems to be that the bill should be signed before July 4 ([A#14120524006]).

Senate Sponsor and Result	Description
Manager’s Floor Amendment
Tom Harkin, D-Iowa, and Michael Enzi, R-Wyo. Approved by unanimous consent	The final bill update before floor amendments were considered included placeholder language outlining a lot-level tracking system for drug shipments favored by industry, but which FDA believes will not deal with existing supply chain problems. It would not preempt any state tracking regulations ([A#14120521006]). It also mandated a nanotechnology regulatory science program to enhance knowledge about how the materials would affect medical products and reports on problems with online pharmacies and the extent of inclusion of demographic subgroup information in clinical trial data. A previous manager’s amendment incorporated new language encouraging FDA to accept foreign clinical trial data when making approval decisions and required increased patient participation during the drug development process Also see "User Fee Bill Reemerges In Senate With Minor Tweaks, But More Changes Expected" - Pink Sheet, 17 May, 2012..
Amendments That Passed
Chuck Grassley, R-Iowa Approved by unanimous consent	Would require FDA rulemaking on registration of clinical trials as required in FDAAA. The amendment is intended to ensure the National Institutes of Health finishes regulations for the clinicaltrials.gov program within about a year Also see "ClinicalTrials.gov: NIH Busy Educating Sponsors On Mandates While Regs Remain In The Works" - Pink Sheet, 23 January, 2012.. The amendment also will require a Government Accountability Office study of compliance with the regulations two years after the final rule is issued. Grassley said the U.S. needs stronger reporting standards for a better understanding of the implications of the increasing number of trials conducted overseas.
Joe Manchin, D-W.V. Approved by unanimous consent	Would reclassify hydrocodone from Schedule III to Schedule II under the Controlled Substances Act. Manchin said the amendment will help fight prescription drug abuse by making the drugs tougher to obtain. Attorney John Gilbert Jr., of Hyman, Phelps & McNamara, said the change would limit the supplies available to patients by no longer allowing refills without a new prescription. Pharmacies also may have to expand their safes where Schedule II drugs typically are stored to make room for the hydrocodone products, which are among the most popular prescriptions in the U.S.
Benjamin Cardin, D-Md., and Mary Landrieu, D-La. Approved by unanimous consent	Would require FDA to issue a report on staff related to small business offices and a summary of outreach efforts. The report also would include the barriers small businesses encounter in the drug and device approval process and require recommendations to alleviate drug shortages.
Grassley Approved by unanimous consent	Would protect members of the Public Health Service Commissioned Corps. under federal whistleblower statutes. It would fix an anomaly in the law created by federal court rulings that said uniformed members of the Commissioned Corps. are not covered by the civilian or military whistleblower laws. The issue stems from a case where FDA officials monitored the personal e-mail accounts and computer activity of radiological device reviewers after they reported wrongdoing to Congress. Six current and former FDA employees sued the agency in January over the case Also see "FDA Spyware Suit: Whistleblowers Challenge Agency Over Email Surveillance" - Pink Sheet, 6 February, 2012..
Cardin Approved by unanimous consent	Would require FDA to review and modify its communication plans to inform and educate providers, patients and payers with particular focus on underrepresented subpopulations, including racial subgroups.
Richard Burr, R-N.C., and Tom Coburn, R-Okla. Approved by unanimous consent	Would require an independent assessment of the drug application review process with a focus on best practices for a predictable review and elements that can save time. FDA also would have to write implementation plans for the recommendations. Coburn said a similar assessment is being conducted for the device review process.
Rob Portman, R-Ohio Approved by unanimous consent	Would require establishment of interoperability standards for prescription information exchange across state lines.
Patrick Leahy, D-Vt. Approved by unanimous consent, although not on the agreed list of amendments	Would not require confidential information FDA receives from other countries to be released under the Freedom of Information Act if requested to be kept confidential. Withholding could last up to three years or until specified. The proposal appears related to FDA plans to share inspection and other information with foreign regulators as part of its globalization strategy. The agency eventually could use inspection data from European Union or other countries to better target resources Also see "FDA’s Globalization Strategy Needs To Be More Aggressive, Sen. Brown Suggests" - Pink Sheet, 20 April, 2012..
Jack Reed, D-R.I. Approved by unanimous consent	Would require compliance with an FDA rule on labeling and effectiveness testing for sunscreens by Dec. 17, 2013 for products with annual sales less than $25,000 and Dec. 17, 2012 for all other products.
Portman Approved by voice vote	Would add cannabimimetic agents to the list of Schedule I controlled substances. Gilbert said the amendment likely is an effort to delete gray areas in the law to ensure the agents are classified as intended.
Amendments That Failed Or Were Withdrawn
Jeff Bingaman, D-N.M. Vote: 67-28 against; required a 60-vote threshold for passage	Would attempt to end pay-for-delay settlements by requiring a generic firm to win its patent challenge in order to receive 180-day exclusivity.
John McCain, R-Ariz. Vote: 54-43 against; required a 60-vote threshold for passage	Would allow drug importation from qualified pharmacies in Canada.
Bernard Sanders, I-Vt. Vote: 88-9 against; required a 60-vote threshold for passage	Would revoke product exclusivity for companies convicted of fraud, adulteration, illegal marketing and other crimes.
Rand Paul, R-Ky. Amendment was tabled by a 78-15 vote	Would not allow the federal government to prevent use of food and dietary supplement claims unless a federal court finds the claim is false and there is no less speech-restrictive alternative, such as a disclaimer. Amendment also would prevent FDA officials from carrying firearms and making arrests without warrants.
Richard Durbin, D-Ill., and Richard Blumenthal, D-Ct. Amendment was tabled by a 77-20 vote	Would require dietary supplement manufacturers to register their facilities as well as disclose a copy of product labels and ingredients.
Burr and Coburn Withdrawn	Would allow members of Congress or their staff to observe prescription drug, generic drug, biosimilar and device user fee negotiations.
Burr and Coburn Withdrawn	Would create a system of performance awards based on FDA employees’ contribution to user fee agreement goals.
Amendments Not Considered
Sanders	Would require drug firms submitting applications to FDA to disclose R&D costs, including pre-clinical and clinical trial spending and all grants and incentives received. Information would be made public.
Blumenthal	Would prohibit market manipulation connected to the sale of drugs in shortage and anyone from distributing false shortage information.
Blumenthal	Would require FDA to create criteria to identify drugs vulnerable to a shortage and allow FDA to award incentives for rapid production or to maintain production of a vulnerable or reinforcement product. Incentives would include expedited application review and fee waivers.
Kristen Gillibrand, D-N.Y., and Blumenthal	FDA would have to issue regulations of authoring, content, format and dissemination requirements for patient medication information. PMI documents must be based on approved labeling and include non-technical language, drug uses, directions for use and side effects. Updates would be applied across similar products and be stored in an electronic repository.
Al Franken, D-Minn., Charles Schumer, D-N.Y., Amy Klobuchar, D-Minn., Cardin and Blumenthal	Would establish civil penalties for knowingly failing to submit a shortage notification to FDA. Penalty would not exceed $10,000 per day up to $1.8 million total.
Jeff Merkley, D-Ore., Schumer and Blumenthal	Would allow the president to issue an executive order declaring a six-month drug market shortage period, making it illegal to sell the shortage drug at an unreasonable price.
Schumer	Would increase penalties for theft of medical products.
John D. Rockefeller IV, D-W.V.	Would prevent NDA holders from making or distributing authorized generic drugs or allowing another manufacturer to make or sell them.
Herb Kohl, D-Wis., Tim Johnson, D-S.D., Sherrod Brown, D-Ohio, Jeff Bingaman, D-N.M., Sanders, Grassley, Klobuchar, and Franken	Would implement the Preserve Access to Generics Act, which would make pay-for-delay settlements presumed anticompetitive if an ANDA filer receives anything of value and agrees to limit or forgo research, development, manufacturing, marketing or sales for a set time. Would not apply if procompetitive benefits are demonstrated Also see "Patent Settlement Bill Advances - And Firms Fight Back With Examples Of Early Generic Launches That Would Be Prohibited" - Pink Sheet, 19 July, 2010.. Bill was aimed at helping the Federal Trade Commission prevent the settlements, which it believes are anti-competitive Also see "FTC Rulemaking Could Be Next (And Last?) Attempt To Curb "Pay-For-Delay"" - Pink Sheet, 6 December, 2010..
Kohl, Grassley and Blumenthal	Would require development of a standardized protocol for health care providers to obtain informed consent from an older individual with dementia before giving an antipsychotic medication.
Sheldon Whitehouse, D-R.I., and Grassley	Would allow FDA subpoena authority to conduct investigations.
Rockefeller	Would mandate practitioner training in order to be registered by the Drug Enforcement Administration to prescribe opioids Also see "Opioid Prescriber Education Mandate Could Be Added To User Fee Bill" - Pink Sheet, 23 May, 2012..
Olympia Snowe, R-Maine, David Vitter, R-La., McCain, Klobuchar and Jeanne Shaheen, D-N.H.	Would allow drug importation by consumers for personal use, registered importers or pharmacies.
Jim DeMint, R-S.C., and Vitter	Would require the White House to give all documents and correspondence between the Pharmaceutical Research and Manufacturers of America and Executive Office of the President since Jan. 20, 2009 to Congress and post them on the Department of Health and Human Services website. Appears related to the recent House Energy and Commerce Committee release of information related to the deal between PhRMA and the White House during the health care reform debate.
Device-related Amendments
Orrin Hatch, R-Utah, Lamar Alexander, R-Tenn., Pat Roberts, R-Kan., and Burr Did not receive a vote	Limits reclassification of devices.
Hatch and 21 others Did not receive a vote	Would repeal the medical device excise tax included in the Health Care and Education Reconciliation Act of 2010, which is part of the health care reform law.
Amendments Not Related To Medical Products
Lisa Murkowski, R-Alaska Vote: 50-46 against; required a 60-vote threshold for passage	Would require an analysis of environmental and economic impact of genetically-engineered fish before FDA can approve genetically-modified salmon.
Vitter Did not receive a vote	Would make changes to the National Flood Insurance Program. Majority Leader Harry Reid, D-Nev., said the Senate would look at the issue during the next work period.

PDUFA Reaches Approval Altitude; Can House Maintain Senate Speed?

More from United States

More from North America