FDA’s months-long and likely tense fight over what policy changes Congress will make in user fee legislation should begin nearing its conclusion within a few days.

The House Energy and Commerce Health Subcommittee and Senate Health, Education, Labor and Pensions Committee are expected to mark up draft versions of their bills this week. The Senate will mark up what it has named the Food and Drug Administration Safety and Innovation Act (FDASIA) April 25. The House is considering scheduling its mark-up the next day, but as of April 20 had not made an official announcement.

After months of debate and many FDA reform bills being introduced, the mark-ups should be the last chance for significant policy changes to get into the legislation, if not already included in drafts. After mark-up, the only real hurdle the legislation would have in either chamber would be an attempt to amend it on the Senate floor, which has much more freewheeling rules of the debate than the House.

Both committees already have released discussion drafts codifying the user fee agreements and most major policy changes, but the House draft remains incomplete. Both pieces of legislation are missing items on FDA’s wishlist, but mark-up will give the agency a much clearer picture of what agency changes are coming.

For example, no agreement has been reached on boosting pharmaceutical supply chain security, namely what type of tracking system should be implemented. FDA wants a track and trace system that will allow electronic unit-level, real-time tracking of drugs in the hopes of preventing adulterated drugs from re-entering the supply chain and other problems. Industry argues that system would be too expensive for many companies to implement.

Some House members want to implement an industry coalition proposal that would allow lot-level tracking and serialization. FDA has said that proposal would not be worth implementing because it would not accomplish the goals of a tracking system.

The Senate draft had a section that would have been devoted to drug distribution security, but it was deleted, according to a “redline” version of the bill. Senators already have written language outlining new authority for FDA to share information with trusted foreign regulators and use third parties to conduct foreign manufacturer inspections, which is not in the House draft, but seemingly would be part of the missing supply chain security section ([A#00120423023]).

There also may be a final push to add a new approval pathway for antibiotics, which also does not appear in either draft. The Infectious Diseases Society of America, with tacit FDA support, has been pushing to get its Limited Population Antibacterial Drug pathway added to a section on antibiotics development incentives. Rep. Henry Waxman, D-Calif., the ranking member of the House Energy and Commerce Committee, has indicated some interest in the idea, but questions remain.

Rep. Phil Gingrey, R-Ga., who is a sponsor of the bill outlining the antibiotic incentives already in the draft, said industry has questions about including it at such a late date Also see "Antibiotic Incentives: FDA’s Woodcock Says LPAD Could Be Better Than Exclusivity, But Questions Remain" - Pink Sheet, 19 April, 2012..

Once the mark-ups are concluded and the bills pass the respective chambers – they have been designated must-pass – conferees likely will have some differences to hammer out before the bill can head to the President’s desk. That clock already is ticking. House leaders have said they want the bill signed by June Also see "How "Clean" Will PDFUA V Be? Rep. Pitts Explains His Vacuuming Technique" - Pink Sheet, 18 July, 2011..

Differences in the Draft User Fee Bills
House Draft	Senate Draft	Possible Outcome
Best Pharmaceuticals for Children and Pediatric Research Equity Act Renewals
Includes permanent reauthorization of both bills, which are set to expire Oct. 1.	An agreement has been delayed while a cost offset is determined Also see "Pediatric Reauthorization In Senate Hits Pothole From Cost Offset For Exclusivity" - Pink Sheet, 19 April, 2012..	Both programs have been successful in generating more drugs for children and almost certainly will be renewed permanently.
Conflict of Interest Rules for Advisory Committees
Would strike entire section of law dealing with conflict of interest waivers and restrictions on advisory committee member recruitment Also see "Conflict Of Interest Rules Get Clean Sweep In House Draft User Fee Bill" - Pink Sheet, 19 March, 2012..	Not included.	Changes have long been expected amid complaints by patient and advocacy groups that FDA rules are excluding valuable experts. It seems likely that the final bill will include some adjustment. However, FDA has said it has not found a legislative solution in the area that would significantly enhance conflict of interest reviews.
FDA Mission And Outreach
Would require three months’ notice before FDA issues a draft guidance and that all guidances be finalized within a year of their release Also see "PDUFA Draft Bill Would Broaden FDA’s Mission, Make Guidance Development More Public" - Pink Sheet, 14 March, 2012..	Not included. A provision would require FDA to issue guidance on drug promotion using the Internet, including social media, within two years.	House language seems less likely to pass because it would place a heavy burden on agency staff and could divert resources away from application reviews and facility inspections. Senate language may have a better chance of passing, although FDA continues to say its Internet and social media guidances are a high priority Also see "User Fee Package Offers FDA Reforms From A House Wary Of FDA Power" - Pink Sheet, 19 March, 2012..
Would add promotion of economic growth and job creation and advancement of medical innovation to the agency mission statement.	Not included.	Less likely, given that FDA has repeatedly said that basing its decisions in part on job creation would be difficult Also see "PDUFA Draft Bill Would Broaden FDA’s Mission, Make Guidance Development More Public" - Pink Sheet, 14 March, 2012..
Drug Shortages
Requires a list be maintained of all drugs in shortage that includes the names of manufacturers, reasons for and expected length of the shortage. Would require the Attorney General to review requests to increase production quotas of controlled substances within 30 days if they could mitigate a shortage.	Requires that FDA compile information on the number of shortage notifications received, shortages that occurred, factors contributing to a shortage, mitigation actions taken, etc.	Both bills include a six-month notification requirement, which is nearly guaranteed to make the final bill. Both also allow FDA to expedite manufacturing changes to prevent or mitigate a shortage, although FDA has said it already has that ability Also see "Drug Shortages: Can The Blame Game Help Find Solutions?" - Pink Sheet, 3 October, 2011.. FDA also already maintains a shortage list, but the possibility of expanding the information in it is possible. Practitioners have asked for duration estimates to help with planning efforts Also see "Drug Shortages: FDA Wants Advanced Warning; Practitioners Want Even More" - Pink Sheet, 26 September, 2011.. Sen. Orrin Hatch, R-Utah, also is circulating a draft bill that would allow reimbursement changes for drugs in shortage ([A#00120423024]).

User Fee Bills: After Mark-ups, How Will House And Senate Reconcile Differences?

More from United States

More from North America