Published May 14, 2012 in Washington Drug Letter
The House Energy & Commerce Committee voted 46-0 Thursday to approve its version of an FDA user fee bill, keeping on track to have the bill signed into law by the end of June.
H.R. 5651, the FDA Reform Act, still lacks a provision to create a track-and-trace system to identify drugs throughout the supply chain. But supporters are busy crafting amendment language to add when the bill hits the House floor later this month.
No amendments were introduced during Thursday’s markup.
The proposed track-and-trace system would likely use lot-level tracking of finished-dose drugs and ingredients, Rep. John Dingell (D-Mich.) told WDL. The amendment should be finalized in time to add to H.R. 5651, he said. Dingell’s Drug Safety Enhancement Act, H.R. 1483, is the basis of the supply chain sections in both H.R. 5651 and the Senate user fee bill, S. 2516.
The FDA and some drugmakers have argued that lot-level tracing wouldn’t provide enough information to track counterfeiters in real time (WDL, March 12). Meanwhile, a more granular level of tracking, such as by unit or vial, may be too burdensome for some companies.
Rep. Jim Matheson (D-Utah) spoke out for a track-and-trace system during Thursday’s markup, saying lawmakers want to craft a proposal that is effective but not overly burdensome. Congress has gained the support of drug industry stakeholders for a lot-level system. However, a final consensus between the FDA, Congress and drugmakers has not yet been reached.
Senate Could Vote Next Week
S. 2516, the FDA Safety and Innovation Act, also lacks track-and-trace language. That bill cleared the chamber’s Health, Education, Labor & Pensions Committee last month and the full Senate could vote on it next week (WDL, April 30). No votes are scheduled yet in either chamber.
In an April 25 Senate markup, Sen. Richard Burr (R-N.C.) offered an amendment that would have created a national track-and-trace system but it was withdrawn and held for a floor vote.
The track-and-trace system has gained momentum only in the last couple of weeks, congressional aides told WDL after the Thursday markup. But they are confident there is enough time to reach an agreement on track-and-trace, which now has the support of Democratic and Republican leaders.
H.R. 5651 and S. 2516 would reauthorize the Prescription Drug User Fee Act (PDUFA) and create new user fee programs for generic drugs and biosimilars. While there are some differences between the two bills, they are mostly technical. No issues are likely to delay a swift passage, congressional aides told WDL.
The House lacks a section to create a third-party audit program for drug safety and quality audits, while S. 2516 authorizes such a program. Such a measure was not discussed during the House markup.
But both bills require a bevy of new information from importers and manufacturers to assure product quality and safety.
Each also increases penalties for counterfeiting or adulterating drugs. And much to the FDA’s delight, the agency could share certain proprietary information with trusted foreign governments to better leverage resources.
In addition, both bills require at least six months’ notification from drugmakers of manufacturing changes that could lead to drug shortages.
In a difference from the Senate, the House bill would shorten — from 180 days to 150 days — the time by which the FDA must respond to a citizen petition requesting a stay of action on an ANDA or 505(b)(2) application.
In a House victory for generic-drug makers, H.R. 5651 would also extend — from 30 months to 60 months — the time by which a first-filed ANDA must be approved in order to gain 180 days of exclusivity.
However, only the Senate bill includes a provision saying risk management programs and other conditions of safe use cannot be used to prevent a drug developer from gaining access to a drug to conduct bioequivalence studies for generic-drug applications.
Both bills also include language based on Sen. Kay Hagan’s (D-N.C.) Transforming the Regulatory Environment to Accelerate Access to Treatments Act, S. 2113. This provision would allow sponsors to request accelerated approval and the FDA would have to approve or deny the request within 60 days. The bills would also give the FDA greater flexibility to approve a drug using surrogate endpoints (WDL, April 9).
Find H.R. 5651 at www.fdanews.com/ext/files/05-11-12-House.pdf. View S. 2516 at www.fdanews.com/ext/files/05-11-12-Senate.pdf. — David Pittman