Congress ratcheted up the pressure on the FDA user fee bill conference committee by leaving some important issues unresolved in the name of bipartisanship and speedy legislating.

The House quickly approved the package May 30, voting 387-5 to pass it on the suspension calendar; the Senate had overwhelmingly endorsed its version the week before. House approval became much easier after a pay-for provision was expanded to ensure the bill would not increase the federal deficit ([A#14120530005]).

Convincing leadership to allow the bill to go under suspension of the rules may be a significant accomplishment, because the expedited voting procedure, which does not allow amendments, is usually reserved for non-controversial items.

However, in order to move the bill quickly, several key issues were left to be decided (see chart). Chief among them is a drug tracking standard. Both chambers punted on the measure, with the Senate bill including only placeholder language and the House leaving the issue completely unaddressed ([A#14120524006]). Negotiators also likely will have to choose a deficit-reduction provision, as each version contains a different proposal Also see "PDUFA Cost Offset In House Focuses On FDA Petition Review, Not REMS" - Pink Sheet, 28 May, 2012..

The House version also includes some measures that could be problematic for FDA, such as a requirement that guidances be finalized within 24 months of the draft being issued. The well-intentioned reclassification of hydrocodone products as a Schedule II controlled substance has garnered opposition from pharmacy groups who claim it will increase drug costs. According to a Congressional Research Service report, there are myriad differences between the two bills across a variety of topics.

Negotiators do not have long to iron out the differences. Leaders in both chambers want the bill sent to President Obama by the end of June. But no formal conference committee is expected, meaning no extensive lobbying or contentious meetings. One source said negotiations could be finished in days.

Comparing Major Differences In The House And Senate User Fee Bills
House Bill, Passed May 30	Senate Bill, Passed May 24	Possible Reconciliation
Drug shipment tracking standards
Not included	Placeholder language only	The language included in the Senate bill outlines most of the industry-favored proposal, RxTEC, but does not preempt any state drug tracking laws ([A#14120521006]). Rep. G.K. Butterfield, D-N.C., said during floor debate he wanted that proposal added in part because it would lower costs and regulatory burdens. FDA remains a stumbling block, however. Agency officials have said the status quo is better than implementing RxTEC ([A#00120423023]). Butterfield also asked FDA and other parties to work together and write acceptable language for the final bill. Industry is intent on getting a national standard to preempt various state tracking proposals that are being implemented, which means there is a strong likelihood the conference committee will produce a compromise with or without FDA agreement.
Antibiotic incentives
Generating Antibiotic Incentives Now (GAIN) Act included, but sets list of pathogens eligible for incentives. Allows others to be added by FDA.	GAIN Act included, but with a less prescriptive definition for eligibility that the Congressional Budget Office expects will result in fewer products receiving the reward. Additional exclusivity could go to antibiotics treating life-threatening infections, including pathogens listed as examples.	FDA is behind the bill, but wants the freedom to choose the diseases eligible for the incentive Also see "FDA Antibiotic Legislation Should Focus On Criteria, Not Bacteria, Woodcock Says" - Pink Sheet, 8 March, 2012.. During the committee mark-up, House members disagreed over the extent of the incentive. Rep. Henry Waxman, D-Calif., said it should be more targeted ([A#00120514019]). The Senate language could win out because FDA and industry likely would be aligned against opponents. Both would not want the incentive’s use limited because the field evolves quickly. But Republicans may want to give FDA more specific instructions on antibiotic development.
Reclassification of hydrocodone
Not included	Would elevate hydrocodone from schedule III to schedule II. Added by floor amendment.	The Senate amendment – offered by Joe Manchin, D-W.V., and approved by unanimous consent – was couched as a method of fighting prescription drug abuse by forcing the products to be stored in a more secure location and no longer allowing refills without a new prescription. Rep. Vern Buchanan, R-Fla., who sponsored a related bill, encouraged the House conferees to include it in the final package. Rep. Fred Upton, R-Mich., chair of the House Energy and Commerce Committee, said he hoped the issue could be worked out. Those who thought the Senate language would easily get into the final bill now face a battle. Several pharmacist associations oppose to the idea, saying in a letter to all members of Congress that the change would increase dispensing costs and adversely affect the quality of life of patients with chronic pain.
Methods to ensure deficit neutrality
Would apply speedier decision deadlines for citizen petitions to biosimilars and require quicker reviews of petitions seeking a determination that safety and effectiveness were not the reason for a brand drug withdrawal. Added in updated manager’s amendment.	Would make it easier for generic firms to gain access to brand drugs subject to a Risk Evaluation and Mitigation Strategy for testing. Addressed in a colloquy during the committee mark-up.	The Congressional Budget Office said the House pay-for would save more money than the Senate proposal in the short- and long-term, which may give its negotiators an edge. The Generic Pharmaceutical Association strongly supports the Senate pay-for, but neither it nor the Pharmaceutical Research and Manufacturers of America are naming favorites, at least not publicly. It is unclear at this point which pay-for will be included in the final bill. Congressional loyalties to the brand and generic industry may end up influencing the decision.
Public participation in guidance development
Would require FDA to give notice that it is formulating draft guidance to allow public input and require drafts to be finalized no later than 18 months after the comment period closes, with a six-month delay possible. Drafts not finalized in time would be considered null and void.	Not included	The House proposal would make the guidance process much more rigid and likely require FDA to devote more personnel to the process, which would be difficult with an already strained budget where other issues take priority Also see "User Fee Package Offers FDA Reforms From A House Wary Of FDA Power" - Pink Sheet, 19 March, 2012.. It is intended as a way to bring more certainty to the guidance process, but almost certainly will not appear in the final bill, in part because of expected strong agency opposition.
Secrecy of confidential information received from other countries
Provisions allowing confidential information, if requested by a local, state or foreign government, to be exempt from the Freedom of Information Act.	Would exempt information received from other countries that is requested to be kept confidential from disclosure under the Freedom of Information Act or if meets other conditions. Added as a floor amendment by Sen. Patrick Leahy, D-Vt.	The proposal seems to be part of FDA efforts to expand its information-sharing programs with other countries. The agency eventually wants to better target its resources by using data gathered by trusted foreign regulators, which is part of the agency’s globalization strategy Also see "Foreign Regulatory Systems Can Be Strengthened By Receiving FDA Inspection Data, IOM Says" - Pink Sheet, 9 April, 2012.. Public Citizen and other open government advocates are against the House language and want it narrowed to avoid “unintentionally or unnecessarily increasing secrecy at the FDA,” the groups said in a letter to Upton and Waxman, the Energy and Commerce Committee ranking Democratic member. The provision could be narrowed to only refer to foreign governments’ facility inspection information if there is enough public pressure. Seems unlikely the provision will be deleted entirely by the conference committee.
Drug shortages
Allows Attorney General to adjust controlled substances production quotas in a shortage situation, if necessary.	Requires a study of market factors contributing to drug shortages and hoarding.	The market factors study appears to be in response to efforts to consider reimbursement payments as an option to prevent and mitigate shortages. Sen. Orrin Hatch, R-Utah, offered a draft bill, but it was not included in the final user fee package ([A#00120423024]). The study could remain in the final bill and used to justify more shortage mitigation efforts later. The Senate bill did not include the production quota provision, but it also could make it into the final bill. The American Society of Hematology also said it wanted a provision in the House bill removed that would exempt products made from human plasma proteins and recombinant products replacing human tissue from the early warning requirement.
Local-acting bioequivalence
FDA directed to report to Congress on “amounts spent, data generated, and activities undertaken, including any FDA advisory committee consideration,” related to development of approval standards for generics of local-acting products.	Not included	The request for a report seems relatively mild, if simply a hassle for FDA on the way to a long-held goal: clearer standards for ANDAs of topically acting products. But the House language may not survive because it appears to be the result of lobbying by Endo International PLC as an effort to protect Lidoderm (lidocaine patch 5%). In addition to an unfavorable New York Times story, the language could face opposition from an unusual source for a brand-friendly provision: Hatch. Watson, the first generic filer of a Lidoderm ANDA, hopes to manufacturer the product in its Utah plant. Allergan PLC announced a patent suit settlement with Endo on May 29, under which it would be able launch an authorized generic on Sept. 15, 2013 if its ANDA is approved.
Bill title
FDA Reform Act of 2012	FDA Safety and Innovation Act	This seems like an innocuous point, but the acronym that will be used in the future is considered important for marketing the package. FDAAA, short for the FDA Amendments Act of 2007, was considered a dud as an acronym. Stakeholders are hoping for something more like PDUFA when the user fee package is finalized Also see "Biosimilars: FDA Trying Group-Think Negotiating Strategy For User Fee" - Pink Sheet, 16 May, 2011.. FDARA could have served as the 2007 acronym if FDA Revitalization Act had been the title as some suggested. It or FDASIA may end up passing muster in the acronym department. But the Senate name seems more indicative of the bill’s intent, which could give it an advantage.

User Fee Conference Cmte. Could Be Relatively Messy After Clean Floor Votes

More from United States

More from North America