In a rare show of bipartisanship, the Senate voted 96 – 1 to fund the Food and Drug Administration (FDA), a regulatory powerhouse with far-reaching influence over the foods Americans eat and the medicines they take. The bill’s goal is to speed approval of new drugs and devices and ensure food safety. It reauthorizes fees from companies like Johnson & Johnson, Medtronic, Inc. and Roche Holding AG that facilitate FDA evaluation of new medical products prior to approval.
These user fees could provide approximately 50 percent of the FDA’s proposed $4.5 billion budget for 2013. The FDA regulates products that make up nearly 25 percent of the American economy. Similar legislation has passed a House committee with support from both sides of the aisle and may move to the full House for a vote quickly. Senate leaders sped the bill through the chamber, emphasizing its importance in protecting consumer safety and promoting innovation in medicine.
“This bill is a shining example of what we can achieve when we all work together,” said Senator Tom Harkin (D-IA), who chairs the Senate committee that oversees the FDA. Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the American market but must be renewed every five years. The current version will expire in September. Additionally, for the first time the FDA will also collect fees from makers of generic drugs and of copycat versions of complex biotech drugs, known as biosimilars. “We’ve worked on this bill for 18 months,” Harkin said as he and ranking member Mike Enzi (R-WY) refereed the mostly cordial debate. The two led opposition to all of the amendments that came up for a vote, and all were defeated.
Senator John McCain (R-AZ) proposed an amendment that would let Americans import drugs from approved Canadian pharmacies. “In a normal world, this would require a voice vote,” McCain said. “But what we’re about to see is the incredible influence of special interests here, particularly (the Pharmaceutical Manufacturers Association).” Senator Robert Menendez (D-NJ) argued that it’s not about the special interests. “It’s about the health and security of the American people, which is why time after time the Senate has rejected it,” Menendez said.
Senator Bernie Sanders (I-VT), who cast the sole “no” vote, got a vote on his amendment to take away exclusive marketing rights from drug makers if a company is found to be at fault for fraud involving a particular drug. The measure failed overwhelmingly, 9-88. “Almost every drug company in this country is perpetrating fraud,” Sanders said. “They’re ripping off Medicare; they’re ripping off Medicaid; and they’re ripping off the American consumer.”
The bill’s speedy passage surprised onlookers accustomed to the usual congressional gridlock. “I haven’t seen anything move this fast in a long time,” said Lisa Swirsky, a senior policy analyst at Consumers Union. “Congress is actually working. It’s kind of like you learned about it in high school.” Nevertheless, consumer advocates have mixed feelings about the Senate bill that now goes to the House. “If you look back at what we saw in the House in December, you know this could have been a lot worse,” Swirsky said. She noted that she was “deeply disappointed” that some provisions consumer groups were pursuing to toughen FDA’s review of medical devices did not make it into the bill. “I would say it’s bittersweet but mostly bitter.”
For more than seven decades, the FDA has primarily inspected U.S. factories. In recent years, pharmaceutical companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008 the number of American drugs made overseas doubled, according FDA figures. Today approximately 80 percent of the ingredients used in U.S. medicines are made in other countries.
The Senate bill will end a requirement that the FDA inspect all American factories every two years, and give the agency increased discretion to focus on foreign facilities. At present, the FDA inspects the typical foreign manufacturing facility once every nine years. Under the bill, FDA inspectors will target the most problematic manufacturing sites, no matter where they are located. “This puts domestic and international facilities on an even playing field for the first time,” said Allen Coukell of the Pew Charitable Trusts, which has advocated for increased drug safety. “It says to FDA, ‘you should inspect the highest risk facilities first, no matter where they are in the world.’”
“These are all the steps American families already think we have in place to protect them,” said Senator Michael Bennet, (D-CO), one of the bill’s authors. “I cannot tell you how many town halls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected.”