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Senate Passes PDUFA V; Next Stop: President’s Signature

By Mari Serebrov
Washington Editor

A week ahead of its self-imposed July 4 deadline, the Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA) Tuesday, reauthorizing PDUFA for another five years. Now all the user-fee package needs is the president’s signature so it can go into effect Oct. 1 .

The Senate voted 92-4 to pass the bill, which creates new user fees for generics and biosimilars, increases the fees for drugs and devices and sets new performance goals. It also provides incentives for new antibiotics and makes two pediatric bills permanent. The House unanimously passed FDASIA last week. (See BioWorld Today, June 21 , 2012.)

In comments on the Senate floor Tuesday, several senators praised the bill and the bipartisan effort to get it passed as soon as possible. But not all the comments were positive. Sen. Richard Burr (R-N.C.) took issue with rushing such a “crucial piece of legislation” through Congress. In the haste, he said, important provisions like a track-and-trace system for drugs were sacrificed.

While there are good provisions in PDUFA V, “more work needs to be done,” Burr said. Several organizations, including the Government Accountability Office, have been critical of the FDA’s lack of performance metrics. But FDASIA doesn’t address the performance problems at the agency, he claimed.

The user-fee reauthorization will give the FDA an unprecedented level of user fees. With that, Burr said, there should be unprecedented transparency in the agency’s reviews and accountability.

Sen. Tom Harkin (D-Iowa), who sponsored the bill, said it was not rushed. Had it been, it could not have gotten so much support in both the House and Senate, he added.

Earlier in the day, Sen. Joe Manchin (D-W.Va.) stressed the need for legislation to reschedule hydrocodone products from Schedule III to Schedule II controlled substances. The provision had been accepted as an amendment to the Senate PDUFA bill, but it was cut from the final bill that reconciled the Senate and House provisions after the Generic Pharmaceutical Association (GPhA) objected to it.

GPhA claimed the amendment would restrict access and increase prices to the pain drugs. (See BioWorld Today, May 24, 2012, May 29, 2012, and June 18, 2012.)

Calling hydrocodone abuse a problem of epidemic proportions that “touches everyone’s life,” Manchin said the public good should outweigh business plans geared on making money. Citing several reports, the senator noted that in 2010, there were more than 28,000 toxic exposures to hydrocodone, 23 million Americans have admitted to abusing the drug and 40 people die every day because of hydrocodone and similar drugs.