Taking the fifth

WASHINGTON, D.C.—In a rare show of consensus not occasionedby some feel-good commemoration, the Prescription Drug User Fee Act (PDUFA)reauthorization legislation passed the U.S. Senate (as S. 3187) by a vote of96–1, while the companion bill passed the U.S. House of Representatives (H.R.5651) by a vote of 387–5.

In the House, the PDUFA bill was voted on under suspensionof the rules, meaning that no amendments could be offered and two-thirds of theHouse had to vote for the bill for it to pass. The Senate did consider severalamendments.

Next, the House and Senate must reconcile their differencesin their respective versions of the PDUFA, according to American PharmacistsAssociation (APhA) Senior Lobbyist Michael S. Spira. Congressional leadersbelieve a PDUFA bill will pass Congress by early summer so that PresidentBarack Obama can sign the bill into law.

The APhA was quoted as being pleased with the bill, butobjected to a drug importation amendment attached to the Senate version. Whenthe APhA was alerted to the possibility of drug importation amendments beingoffered during the Senate floor debate, the association took action, sending aletter urging senators to vote against any drug importation amendments.

"While the APhA supports efforts to increase patients'access to appropriate prescription medications, proposals to legalizeprescription drug importation do not ensure the integrity of the U.S. drugsupply, could fracture patient care and could possibly hurt the very patientsthe medications are intended to help," the letter stated.

In the end, one drug importation amendment was voted on, butfailed to pass the Senate. The Senate did pass an amendment to reclassify allhydrocodone-containing products from Schedule III to Schedule II.

"We have been very active on this issue" on both theregulatory and legislative sides, meeting with stakeholders and members ofCongress, Spira told pharmacist.com. "We are happy with the bill."

PDUFA—a proposed user-fee program for brand-nameprescription drugs—and three similar programs for medical devices, genericdrugs and biosimilars are in both the House and Senate bills. Originallyenacted in 1992 and requiring reauthorization every five years, the legislationbeing considered by Congress is the fifth reauthorization of PDUFA, referred toas PDUFA V. The legislation authorizes the U.S. Food and Drug Administration(FDA) to collect user fees from industry to help fund the agency's timelyreview of applications.

Included in the PDUFA agreement between the FDA andmanufacturers on how the FDA intends to use the fees is language onstandardizing Risk Evaluation and Mitigation Strategy (REMS), biomarkers andpharmacogenomics and the FDA's Sentinel system. REMS for drugs and biologicswas established in Title IX of the FDA Amendments Act of 2007 (FDAAA), whichpermits the FDA to require the applicant for a new drug application, biologicslicense application, abbreviated new drug application or a supplement thereofto submit a proposed REMS as part of the application prior to approval if theagency determines that it is "necessary to ensure that the benefits of the drugoutweigh the risks of the drug."

The Biomarker Qualification Program was established tosupport the FDA's Center for Drug Evaluation and Research's (CDER) work withexternal scientists and clinicians in developing biomarkers. As an interofficecollaborative endeavor within CDER, the program offers a formal process toguide submitters as they develop biomarkers and rigorously evaluate them foruse in the regulatory process. Less well developed to date is the program tostandardize specific uses of pharmacogenomics data in drug development andlabeling.

The Sentinel system will ultimately be a national electronicsystem aimed at enhancing the agency's ability to track the safety of drugs,biologics and medical devices once they reach the market. Launched in May 2008,the Sentinel Initiative aims to develop and implement a proactive system thatwill complement existing systems that the agency has in place to track reportsof adverse events linked to the use of its regulated products.