SENATOR SKEPTICAL OF FDA'S PLAN B ENFORCEMENT STRATEGY
A key lawmaker in the fight over Andrew von Eschenbach's nomination as FDA commissioner is questioning the agency's Plan B enforcement plan as "unprecedented" and possibly a ploy to prevent OTC sale of the drug.
The FDA July 31 unveiled its proposal to approve Barr Pharmaceuticals' controversial contraceptive Plan B (levonorgestrel) for OTC use. Not only is the agency rejecting Barr's proposal to give women under 18 OTC access, but it is establishing an enforcement plan that many observers say is unique. The agency is requiring Barr's subsidiary, Duramed Research, to ensure that the drug is kept behind the counter at pharmacies and dispensed only with production of a valid photo ID establishing the age of the customer.
This requirement has raised the ire of lawmakers such as Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.). The move is "unprecedented and perhaps a behind-the-scenes way to ensure that this application doesn't move," Alex Glass, Murray's spokeswoman, said. "It seems like it would be very difficult to accomplish these requirements."
The senators have accused the agency of dragging its feet on Plan B and are threatening to hold up von Eschenbach's nomination once it reaches the Senate floor.
This requirement for the manufacturer to "police the pharmacy marketplace" is unprecedented, an industry attorney added. There are no other instances of drug companies being "deputized" to enforce agency requirements, the source added.
The agency has previously required risk management plans in order to approve drugs like OxyContin, but the FDA has had enforcement responsibility, not the company. The closest example of this type of arrangement is when the agency requires companies that have instituted a voluntary recall to report to the FDA whether the product has been pulled from the shelves, the source said.