Ideas to Alleviate Drug Shortages Are Plenty at GDUFA Hearing, Which Ones Will Stick Remains to Be Seen
Published Feb. 10, 2012 in Drug Industry Daily
Ideas to Alleviate Drug Shortages Are Plenty at GDUFA Hearing, Which Ones Will Stick Remains to Be SeenMost who are following the user fee bills pending in Congress expect lawmakers to combine the Generic Drug User Fee Act (GDUFA) with legislation to address the escalating problem of drug shortages. The two go together since most drugs on the FDA’s current shortages list are generic injectables.
But even though lawmakers have examined the issue since late last summer and held several hearings in different House and Senate committees, there seems to be little consensus on how to address the issue or what final legislation on drug shortages should look like.
Thursday’s hearing of the House Energy and Commerce health subcommittee on GDUFA, the Biosimilars User Fee Act and drug shortages provided few indications on which way Congress is leaning.
The most talked about idea so far is mandatory notification by drugmakers within six months of any production changes that could lead to shortages. That change is carried in companion bills S. 296 and H.R. 2245 (DID, Feb. 10, 2011).
But David Gaugh, the Generic Pharmaceutical Association’s (GPhA) new vice president for regulatory sciences, expressed concern about the six-month timeframe for notification. There are many circumstances where manufacturers aren’t aware six months in advance that issues will arise, he said at the hearing.
Mylan CEO Heather Bresch, who also testified Thursday, said FDA tightening of the global supply chain and ensuring foreign parity in surveillance inspections would go a long way toward correcting drug shortages. Regular inspections would catch supply chain and manufacturing issues before problems become large enough to shut a plant down.
Ensuring a drug’s pedigree through a track-and-trace system would eliminate manufacturing issues further down the line, she added. The pending GDUFA agreement would achieve foreign inspection parity by the end of the first five-year cycle. It would also accelerate ANDA approvals and get more players on the market for certain drugs in short supply, she said.
Bresch lampooned talk of higher or more flexible reimbursements for certain generic drugs as a way to alleviate shortages, another idea floated by lawmakers (DID, Dec. 1, 2011).
At the hearing, GPhA championed its plan, the Accelerated Recovery Initiative, which would provide an impartial third party to collect current and future supply information from drugmakers to identify supply gaps and allow “voluntary production adjustments” to avert or lessen the impact of a shortage (DID, Dec. 16, 2011).
Some GPhA members are hesitant about the idea, questioning what would be reported to a third party versus the FDA and how much information would remain private, Bresch said. “Efforts can be stepped up on the FDA’s part with voluntary reporting that has gone on for years,” she told DID.
CDER Director Janet Woodcock told lawmakers Thursday she hasn’t had a chance to study the GPhA plan but would work with the group on the issue.
Another recent proposal, introduced by Reps. John Carney (D-Del.) and Larry Bucshon (R-Ind.) this month, would create and expand stockpiles of critical drugs in short supply (DID, Feb. 3).
Meanwhile, hearings will continue on the Generic Drug and Biosimilar User Fee Act of 2012, H.R. 3988, which was introduced Wednesday by Rep. Tim Murphy (R-Pa.). The bill has bipartisan cosponsors in Subcommittee Chair Joe Pitts (R-Pa.) and Reps. Frank Pallone (D-N.J.) and Henry Waxman (D-Calif.).
View H.R. 3988 at www.fdanews.com/ext/files/Bill-Text-112th-Congress.pdf. — David Pittman