HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Thursday, July 31, 2008

Grassley, Dingell Lead Calls for Overhauling FDA

The Wall Street Journal reports that several of this year's crises like the salmonella outbreak have led some members of Congress to scrutinize the FDA and propose giving it broader powers. Alicia Mundy writes,

Fda1Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising.

Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa). A series of crises during the past year, including deaths linked to tainted Chinese-made blood thinners and cases of salmonella linked to jalapeño peppers, have given ammunition to the lawmakers, both longtime critics of the FDA.

A House subcommittee led by Mr. Dingell plans a Thursday hearing on the FDA's response to the salmonella outbreak. Mr. Dingell called it a "disaster." Among those hurt were tomato growers, who lost millions of dollars during the month that their products were thought to be the culprit.

Congress isn't likely to enact major changes to the agency this  year because it has only a brief fall session before the November elections, but 2009 may bring the most significant overhaul at the FDA in a generation if Messrs. Dingell and Grassley get their way.

Billy Tauzin, president of the drug industry's lobby, Pharmaceutical Research and Manufacturers of America, said he has warned members about what may lie ahead. "It's an accumulation of things some companies did over the years. Now it's death by a thousand cuts," he said in an interview. "We gotta stop the bleeding."

Controversies over the popular prescription drugs Chantix, an antismoking pill, and cholesterol treatment Vytorin have added to pressure on the FDA, as critics suggest the agency was too lax in pursuing safety or efficacy concerns.

The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.

FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."

The current FDA commissioner, Andrew von Eschenbach, said the agency is independent of industry influence. In an interview, he said he has been moving to get the agency to act faster on information that a drug may have problems. The heparin crisis demonstrated the challenge to the agency from globalized food and drug supplies, which he described as the biggest issue the FDA faces, but he said the agency's resources are limited.

The pharmaceutical industry is digging in against changes it believes would make it harder to bring innovative drugs to market. Speaking of stricter rules proposed by Mr. Dingell, an industry lobbyist testified this spring: "The FDA currently regulates virtually every stage in the life of a prescription medicine sold in the U.S."

However, drug companies can't afford to appear too aggressive in protecting sales or deflecting stronger safety standards, because that might backfire and prompt embarrassing hearings in Congress.

Leading Democrats would like to see fewer Madison Avenue-style television commercials for prescription drugs. PhRMA earlier this month sent lawyers to meet with staffers for Mr. Dingell's committee and discussed how the industry could preserve its right to advertise medicines directly to consumers. The industry says TV ads help people learn more about diseases and treatments.

To lay the groundwork for their FDA overhaul, Messrs. Dingell and Grassley and their allies have ordered about 20 investigations of drugs and issues involving the FDA. Agency officials have spent hundreds of hours testifying before Congress.

Congressional leaders have directed their frustration at Dr. von Eschenbach, who has led the FDA since December 2006.

After the heparin scandal broke in February, Dr. von Eschenbach at first balked at asking for more money to fund overseas inspections, at one point causing Mr. Dingell to erupt: "You are not the first fellow I've skinned for not doing his job." Finally, on June 9, the commissioner joined the health and human-services secretary in a surprise, night-time news conference. They announced they would formally ask Congress for $275 million for FDA overseas inspections -- for the next fiscal year, ending Sept. 30, 2009.

The move prompted anger from lawmakers who said Dr. von Eschenbach should be seeking the money right away. Sen. Arlen Specter (R., Pa.), usually sympathetic to the agency, called the FDA "a joke." Senate Appropriations Chair Herb Kohl (D., Wis.) privately upbraided Dr. von Eschenbach for undercutting congressional allies, according to Senate staffers.

Mr. Grassley began his campaign to overhaul the FDA in 2004 during an uproar about the agency's slow reaction to potential links between popular antidepressants and teen suicides. Now, he has four staffers and a parade of FDA whistleblowers helping him investigate a plethora of FDA controversies, such as its approval of the antibiotic Ketek. The FDA has cited "serious protocol violations" in clinical trials of Ketek but didn't pursue a criminal case.

Mr. Grassley wants to give safety reviewers complete autonomy from the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials. Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs. An FDA spokeswoman said, "It is not unexpected that at times people will not be unanimous in their views."

Mr. Dingell has a pending bill to add new drug-import registration fees and mandate certification of purity for incoming drug ingredients, among other measures.

"There's a total inability of the FDA to carry out" its mission," said Mr. Dingell, citing the heparin crisis and salmonella outbreak among other issues.

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