WASHINGTON - Multiple industry-relevant issues are in play in Congress right now, many of which are generating a good deal of activity in both the Senate and the House of Representatives. Here's a quick breakdown of some of them:
• Follow-On Biologics: BIO President and CEO Jim Greenwood predicted this would be "the most important legislative item" facing the industry in this Congress. "That's the one I think about in the wee hours of the morning," he told BioWorld Today, particularly in regard to the number of years of data exclusivity given to the brand-name industry, the period of time following an innovator's product approval during which the FDA cannot clear a follow-on that references the innovator's safety and effectiveness. Multiple bills to establish an approval pathway for follow-on biologics are circulating around Capitol Hill, and BIO and other like-minded parties are focused on ensuring 14 years of data exclusivity. "That single provision will have more to do with the profitability and the sustainability of our industry than anything else that Congress will do in this session," Greenwood said. Some of the proposals have been vetted during House and Senate hearings, while others are being bandied about behind closed doors. The relevant Senate committee plans to mark up such legislation by June 13 and insert a follow-on biologics provision into conference work to merge wide-reaching House and Senate bills on the FDA. But Greenwood warned that such a timetable is too quick for lawmakers to "prudently and thoughtfully digest the issues."
• User Fees: The Senate has incorporated language to renew the Prescription Drug User Fee Act (PDUFA) into S. 1082, the "Food and Drug Administration Revitalization Act," for which consideration is continuing this week. Greenwood called it "a good reauthorization," though he admitted disfavor with the Senate's "bad precedent" of increasing user fees beyond the industry-negotiated package put forth by the FDA. House members have held hearings on user fees, and their final language is expected to get merged with the Senate version next month. The existing PDUFA law sunsets on Sept. 30, and FDA officials have said a final agreement is needed at least three months before that to avoid personnel disruptions at the agency.
• Drug Safety: S. 1082 largely is devoted to language that places safety review mandates on new drugs and biologicals upon approval under Risk Evaluation and Mitigation Strategies (REMS), which have been scaled back considerably from their original "draconian" standards, Greenwood said. "We're still not happy with the provisions, but they're moving in the right direction," he added. In the House, though, more strict REMS standards have been proposed. BIO favors improving post-approval surveillance by approaches that mine large databases for safety outcomes.
• Patent Reform: A House hearing two weeks ago brought back to light an issue that has been around for several years now, and some industry observers believe the matter has quite a bit of traction at this point. A bipartisan and bicameral proposal, recently introduced in both chambers, drives at the heart of the matter to make some fundamental changes to the patent system, changes that could make it harder to get new patents and easier to challenge existing ones.
- Aaron Lorenzo