Becoming a Trusted Source in Drug Safety Law’s Passage (Fall 2012 Trust Magazine)

Source Organization: Drug Safety Project

Author: Tim Warren

09/25/2012 - When President Obama signed the FDA Safety and Innovation Act in July, it was the culmination of a strong and rare bipartisan effort by Congress. It also represented a significant victory for proponents in the pharmaceutical industry, medical community and consumer advocates who have been working to bolster the safety and innovation of the nation’s drugs and medical devices.

The new law will increase inspections of overseas drug manufacturers, provide incentives for pharmaceutical companies to develop new antibiotics, bring generic drugs to market more quickly and expand the U.S. Food and Drug Administration’s authority to monitor medical devices, from artificial hips to cardiac defibrillators.

Those provisions were backed by the Pew Health Group, which had begun working with FDA officials and congressional staff more than two years earlier, providing in-depth, data-supported research that helped guide the final legislation. Their efforts illustrated the hallmarks of the way the health group operates—strong policy analysis and the convening of meetings in which Pew acts as a facilitator, bringing together disparate experts and interested parties to find common ground.

It has been successful before. The methodology marked the health group’s approach when it helped champion the first overhaul of the U.S. food safety system since the Great Depression. Pew helped bring together industry representatives and consumer groups and supplied research to support the new law, which Obama signed in January 2011.

On the drug safety legislation, Pew sought early on to be known as a trusted source for policy makers and their staffs, said Allan Coukell, director of the health group’s medical programs. One major step in that area was the release in July 2011 of the report After Heparin, which brought out serious concerns about how U.S. prescription drugs are manufactured and distributed.

“It was read by a wide variety of people—congressional staff, consumers, professionals—and really established our bona fides,” said Coukell, who also testified on Capitol Hill several times about the legislation. “It had detailed case studies and was thoroughly vetted by a number of experts. A lot of people were shocked to hear that 80 percent of drugs were coming from overseas, and that the FDA was essentially absent. The agency would conduct inspections of U.S. drug facilities every two years but overseas it was every nine years, if that.”

Equally important was a conference Pew hosted on the issues raised by After Heparin. “We had a convening of every group out there, from the industry side to the FDA,” said health group managing director Shelley Hearne. “We listened to everybody, and everybody had a say in the recommendations. That document and the conference were really key to the process in which we could sit down and hammer out how those recommendations could be incorporated.”

The success of the report and the conference also affirmed the health group’s conclusion that its policy objectives on drug safety and reviving the antibiotic supply chain could be packaged with upcoming legislation to renew user fees for drug and medical-device manufacturers. A 1992 law—the Prescription Drug User Fee Act, or PDUFA—enabled the FDA to speed its reviews of new drug applications and stipulates the fees must be extended every five years, and the next renewal date was to occur in 2012.

For the first time, makers of generic drugs signaled they wanted to pay user fees, in part to fund inspections of manufacturing sites, particularly those overseas. “U.S. manufacturers saw this as a level-playing-field issue,” Coukell said.

The health group, along with colleagues from Pew’s Government Relations team, spent much of 2011 working with congressional staffers and lawmakers who had taken an interest in drug safety or antibiotics issues. The Government Relations staff has deep experience in how to work on Capitol Hill. Its members know, as Sarah Despres, a senior officer who was key in guiding Pew’s efforts on the Hill, said: “By working with the Hill staffers directly, you earn their trust.” Managing director Tamera Luzzatto noted that staffers “know what their bosses’ impulses are, which issues their bosses will roll up their sleeves for.”

Pew’s meticulous preparation and analyses were noticed by policy makers on both sides of the aisle. Rep. Phil Gingrey (R-Ga.), whose Generating Antibiotic Incentives Now Act was ultimately incorporated into the overall legislation, attended a Pew-sponsored event on developing new antibiotics to treat members of the military. Rep. Henry Waxman (D-Calif.) said at a hearing, “I know that Pew has had a long-standing interest in making sure that we get more antibiotics, new antibiotics, so our arsenal is full.”

As with any major bill on Capitol Hill, there were many advocates, interest groups and others wanting to be heard. “You’ve got to be able to stand out, and Pew did that right up until the final bill was passed,” Luzzatto said. “We made a case for policy change based on fact, and that message resonated.”

Although much was made of the unusually collaborative proceedings on the Hill, getting the final provisions into the bill was no given. “There was tough negotiating and markedly different positions on many, many issues to be worked out,” Coukell said.

When the process reached its final stage—reconciling the House and Senate bills in June—Pew’s effort went into overdrive. “We wrote three long, detailed papers,” Coukell said. “One was on the provision to create incentives for new antibiotics, one was on medical devices, and one was on the supply chain. On antibiotic incentives, for example, we were going through the bill with a fine-tooth comb and trying to very clearly lay out how this would work.

“In a period of a few weeks, we were reacting to a Senate committee draft, a House committee draft, a Senate final draft, a House final draft and then a conference draft,” he continued. “We were going through them over and over and producing detailed analysis, and often responding on short notice to requests from one staff or another for elucidation, or additional analysis or talking points—sometimes on all three of those issues in the same day. We were also in that phase in closed-door sessions with the FDA and the industry over the supply chain provisions.”

In the last, frantic days of negotiating, Pew’s goal of being a trusted source had been met. “The Pew staff had to be available 24/7,” Hearne said. “That is the dream of every organization that wants to do something for the public good.”

Tim Warren is a contributing editor to Trust.

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