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PDUFA Passes the Senate, Awaits Debate on House Floor

From BioWorld Today (May 25, 2012)

WASHINGTON, May 25, 2012 (BIOWORLD TODAY) - Biopharma has cause to celebrate as PDUFA V rolled through the Senate Thursday with little in the way of fireworks.

The FDA Innovation and Safety Act (FDASIA), S. 3187, passed the Senate 96-1 after a full day of debate on various amendments.

"By reauthorizing PDUFA, members of both sides of the aisle have taken an important step forward toward providing the FDA with much-needed resources and management tools," said Matthew Bennett, senior vice president of the Pharmaceutical Research and Manufacturers of America.

While the Senate passage is a good sign that the reauthorization of the user fee package will be in place well before PDUFA IV expires on Sept. 30, it’s a little early to celebrate. The bill still needs House approval.

The House is expected to vote next week on its own version of the fee package. Then the two chambers must come to terms on differences between the two bills. Several congressional leaders have indicated they’d like to have the bill on the president’s desk by July 4.

So far, there aren’t a lot of differences between the bills, which set user fees for brand drugs and medical devices for the next five years, and create new user fees for generic drugs and biosimilars. While the details may vary, both bills include such measures as an enhanced accelerated approval pathway, incentives for development of new antibiotics, required early notification to avert drug shortages and increased supply chain protections. (See BioWorld Today, April 27, 2012, and May 21, 2012.)

Both bills also permanently reauthorize the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act. Like the user fee agreements, the pediatric acts have had five-year sunsets. Making them permanent will "encourage continued investment in pediatric research and help ensure that new drugs and biologics can be used safely and appropriately in pediatric patients," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO).

Whether the minor differences that exist between the House and Senate user fee bills become major will depend on amendments attached in the House. While more than 40 amendments had been proposed for S. 3187, the Senate leadership limited the list to 17 before debate began Wednesday. (See BioWorld Today, May 24, 2012.)

The more controversial amendments were voted down. "We greatly appreciate the Senate defeat of amendments which would have threatened final approval of FDASIA, including an amendment which would have slowed the FDA’s consideration of genetically modified salmon," Greenwood said.

BIO also welcomed the Senate defeat of amendments pertaining to patent settlements, importation and the elimination of innovator data protections.

Sen. Bernie Sanders (I-Vt.), who cast the lone vote against the PDUFA reauthorization package, had proposed an amendment to strip drug exclusivity from companies convicted of fraudulent activity such as off-label promotion. The amendment failed, 9-88, with several senators pointing out that such a measure would chill innovation and keep drug makers from agreeing to settlements on fraud charges.

A few of them, especially those in states populated by drug companies, bristled at Sanders’ characterization of drug makers as the most fraudulent industry in the country. Those companies save lives, said Sen. Robert Menendez (D-N.J.).

Another controversial amendment was Sen. John McCain’s proposal to allow Americans to fill their prescriptions through Canadian pharmacies so they can get more affordable drugs. Several senators argued for the amendment, noting specific examples of how the same drug, made in the same facility, costs hundreds of dollars more in the U.S. than it would in Canada.

Sen. Olympia Snowe (R-Maine) claimed the U.S. would save $20 billion a year if drugs could be imported from Canada. Instead, she said, American taxpayers underwrite the discovery of many of those drugs through the $30 billion in funding given to the National Institutes of Health each year and then they are asked to pay more for them than patients in other countries.

Menendez argued against McCain’s amendment, saying it would open the door to counterfeits as there would be no way to trace the imports to ensure they were safely manufactured. The amendment would provide no resources to allow the FDA to monitor the imported drugs, he added.

When others noted that the majority of drugs sold in Canada come from other countries, Snowe countered that many of the drugs already in the U.S. supply chain come from overseas facilities that have not been inspected by the FDA.

The amendment needed 60 votes to pass; it received 43.

Posted: May 2012