New Allegations of Political and Corporate Pressure on FDA

April 3, 2012 | 4:17 pm
Michael Halpern
Former Contributor

In today’s New York Times, Gardiner Harris describes tensions between the FDA, Congress and the White House regarding the agency’s attempts to inform and protect the public. It’s an incredible article that helps demonstrate the pervasiveness of both political and corporate pressure on the agency, and how those who do not have scientific training in public health attempt to take decision-making authority on what should be scientific issues away from those who do.

Last Thursday, UCS released an analysis showing that drug, medical device, and biotech companies have spent $700 million in recent years lobbying Congress and the executive branch, hundreds of millions more than the oil and gas industry and the insurance industry. Also, in a recent UCS survey, hundreds of FDA scientists reported political and corporate attempts to influence their work.

Senior White House official Cass Sunstein

Senior White House official Cass Sunstien (pictured above) pressured the FDA to delay a ban on the asthma inhaler Primatine Mist. Members of Congress also tried to intervene by writing FDA officials and even introducing legislation to prevent the agency from acting, according to the New York Times. Photo: U.S. Senate

The article considers commercial pressure in the case of the asthma inhaler Primatine Mist. Mr. Harris writes:

“The F.D.A. and the White House disagreed over whether to remove from the market the asthma medicine Primatene Mist because it contained chlorofluorocarbons or CFCs, banned by international treaty because they have been found to deplete the earth’s ozone layer. The F.D.A. had for years warned Primatene’s maker of the impending ban, but the company had not followed other inhaler makers and created a product that did not use CFCs even after an additional year’s reprieve.

Amphastar, Primatene’s maker, underwrote an expensive lobbying campaign to stop the F.D.A.’s planned ban. More than a dozen members of the House signed a letter to the Obama administration asking for an extension of the deadline. Senators Pat Roberts of Kansas and Jim DeMint of South Carolina, both Republicans, introduced legislation that would have barred the F.D.A. from removing Primatene from the market because they said the ban was a burdensome regulation.

The reporter goes on to describe that Cass Sunstein, a senior official at the White House Office of Management and Budget, also got involved:

Such lobbying is not unusual for the F.D.A. What was unusual, several top agency officials said, was the effort by Mr. Sunstein to persuade the agency to give Primatene a reprieve. “Usually, we can ignore all the lobbying stuff. We get it all the time,” a top F.D.A. official said. “But when we get pressure from inside the administration, that’s when it gets really tough.”

Mr. Sunstein must approve new government rules. But in the case of Primatene, the law and rules were already in effect. The F.D.A. did not need his agreement and resisted his entreaties, officials said.

The $700 million in lobbying is paying off as Congress considers giving companies more influence over how the FDA approves drugs and medical devices by allowing more scientists paid by the drug companies to sit on FDA scientific advisory panels that evaluate new products for safety and effectiveness.

UCS is tracking these congressional efforts and making the case for stronger conflict of interest standards at the agency.

We’re also encouraging people to weigh in with personal stories of how drugs and devices have affected them—in both positive and negative ways.  As my colleague Celia Wexler said, a voter can outweigh a dollar, even in these cynical times.