PDUFA legislation passes Senate, then House

APhA pleased with bill; lobbies against proposed Senate drug importation amendment.

Prescription Drug User Fee Act (PDUFA) reauthorization legislation passed the U.S. Senate as the FDA Safety and Innovation Act (S. 3187) May 24 by a vote of 96–1. The companion bill passed the U.S. House of Representatives as the FDA Reform Act (H.R. 5651) May 30 by a vote of 387–5.

In next steps, the House and Senate versions of PDUFA must reconcile their differences, according to APhA Senior Lobbyist Michael S. Spira. Congressional leaders believe a PDUFA bill will pass Congress by early summer so that President Barack Obama can sign the bill into law.

“We have been very active on this issue” on both the regulatory and legislative sides, meeting with stakeholders and Members of Congress, Spira told pharmacist.com. “We are happy with the bill.”

PDUFA—a proposed user fee program for brand-name prescription drugs—and three similar programs for medical devices, generic drugs, and biosimilars are in the House and Senate bills, which are fairly clean with few amendments. PDUFA is up for reauthorization in September 2012; originally enacted in 1992 and requiring reauthorization every 5 years, the legislation being considered by Congress is the fifth reauthorization of PDUFA, referred to as PDUFA V. User fees allow FDA to collect user fees from industry to help fund the agency’s timely review of applications.

Language on drug shortages is included in the legislation. Included in the PDUFA agreement between FDA and manufacturers (on how FDA intends to use the fees) is language on standardizing REMS; biomarkers and pharmacogenomics; and FDA’s Sentinel system. APhA sent a letter to Senate Health, Education, Labor, and Pensions Committee leadership on April 24 supporting the PDUFA program, the proposed PDUFA V legislation, and specifically the Senate’s work on the above four issues.

Members of Congress can alter the language on the House or Senate floors by offering amendments. While the House’s PDUFA bill was voted on under “suspension of the rules,” meaning that no amendments could be offered and two-thirds of the House had to vote for the bill for it to pass, the Senate did consider several amendments. When APhA was alerted to the possibility of drug importation amendments being offered during the Senate floor debate, the Association took action.

On May 21, APhA sent a letter to the Senate offices urging senators to vote against any drug importation amendments. “While APhA supports efforts to increase patients’ access to appropriate prescription medications, proposals to legalize prescription drug importation do not ensure the integrity of the U.S. drug supply, could fracture patient care, and could possibly hurt the very patients the medications are intended to help,” according to the letter.

Also on May 21, APhA signed a letter from the Partnership for Safe Medicines that was against any drug importation amendments. On May 22, APhA sent an e-mail to its Advocacy Key Contacts suggesting that they call their senators to urge them to vote against any such amendments.

In the end, one drug importation amendment was voted on, but it did not pass the Senate.

The Senate did pass an amendment to reclassify all hydrocodone-containing products from Schedule III to Schedule II, however. For more information on that amendment, see another article posted today on pharmacist.com, “Senate passes hydrocodone rescheduling amendment.”