The FDA on Steroids


By David Shook Six months into President Bush's first term, he has yet to appoint his own person to run the U.S. Food & Drug Administration. That doesn't mean the agency responsible for approving new drugs, food, and medical devices is without a strong policy on regulating the pharmaceutical industry. Quite the contrary.

To many in Big Pharma, the FDA this year has become a tougher cop than ever when it comes to drug approvals. By demanding more thorough data on applications and rejecting those that don't have it, the agency sends a message to the pharmaceutical industry: that the pressure to bring new medicines to market cannot stand in the way of consumer safety. The best action Bush can take would be to appoint a commissioner who continues down the path the FDA has taken this year -- that of tough policing of Big Pharma.

SHOTGUN APPROVALS? The regulatory tone at the agency is markedly different from 2000, some experts say, when patient groups and doctors stepped up criticism of the FDA for a series of drug approvals dating back to 1993. They questioned whether regulators were approving drugs too quickly.

The incident that received the most attention involved the approval of Warner-Lambert's Rezulin, a diabetes drug that was linked to hundreds of cases of liver failure during its three years on the market ending in March, 2000. In addition to Rezulin, the FDA in recent years approved Redux, the diet drug marketed by American Home Products (AHP) that caused heart failure in some patients, and Propulsid, the Johnson & Johnson (JNJ) heartburn medication linked to a cardiac disorder. These drugs have been linked to hundreds of often fatal liver or heart failure. "Drugs were getting approved that never should have gotten approval," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.

Of course, some might say the FDA is perpetually between a rock and a hard place. It was the same consumers and doctors who years earlier had griped relentlessly about the approval process taking too long, especially for drugs for terminally ill patients. Reviews became quicker during the Clinton years, but that seems to have changed since Bush took office. Now, the agency is rejecting or delaying new-drug applications right and left -- despite the perception that Bush would be a friend to the powerful pharmaceutical industry.

HARSH ENVIRONMENT. Why? Even without a political appointee at the top, it appears the FDA is far from rudderless. Longtime agency insider Dr. Bernard Schwetz, who has been acting principal deputy commissioner since September, 1999, holds the highest position at the agency. Since the departure in January of Clinton's last FDA commissioner, Jane Henney, Schwetz has been running the show.

Agency spokesman Lawrence Bachorik insists the agency's policies "haven't changed at all." Says Bachorik: The FDA continues to maintain the same high standards when it comes to the review of drugs and other products. We weigh the risks and benefits, and we've been doing that consistently." Try telling that to the drugmakers, who are near shock over what they perceive to be a harsh regulatory environment. Says analyst Michael Krensavage of Raymond James & Co.: "The FDA is becoming harsher, rejecting drugs, issuing warning letters, delaying approvals. It's getting to be a tougher environment for drug companies."

In June, the FDA told Eli Lilly (LLY) that reviewers needed more time to review Xigris, a potential blockbuster treatment for sepsis (an often-deadly reaction to infection experienced by many surgery patients, which can lead to acute organ failure). The agency also blocked Xolair, the asthma drug from Genentech (DNA) and Novartis (NVTS), with a request for additional safety data. Then there was Clarinex, the follow-on drug to Schering-Plough's blockbuster allergy medicine Claritin. Until Schering cleans up its manufacturing practices, the FDA said, it has frozen the review of Clarinex -- a huge blow to the company.

These and other setbacks have cost the industry billions of dollars in revenues and market capitalization. "There's a perception in the industry that the FDA has become more demanding recently, and sometimes excessively so," says the government-affairs director of a major biotech company.

WILL IT LAST? The question now is whether this new tough tone will last. The White House says it's actively seeking the right candidate, and the agency points out that it's not unusual for a newly elected President to take his time deciding who will head the FDA. In recent months, a few names have been mentioned. Duke University cardiac specialist Rob Califf, who couldn't be reached for comment, appears to be a candidate. Ray Woolsley, former president of the American Society for Clinical Pharmacology & Therapeutics, won't be getting the job: He withdrew from consideration and signed on as dean at the University of Arizona's College of Medicine.

Another view in Washington is that the delay could have more to do with politics than regulatory standards. Some experts say Bush may be holding out for a candidate who'll push for a reevaluation of RU-486 -- the abortion pill the agency approved in 2000. Bush's Health & Human Services Secretary, Tommy Thompson, testified at his confirmation hearing that he would review the safety of RU-486. A review could unearth safety problems with the drug, allowing the Administration to prevent the drug from being prescribed in the U.S.

Still, drug companies are watching -- hoping might be more accurate -- to see whether Bush will appoint a commissioner who is more sympathetic to the market pressures facing the industry. "I think the FDA needs someone from academia -- not someone from inside the agency or someone from the pharmaceutical industry," says Dr. Curt Furberg, professor of public health sciences at Wake Forest University.

STAND VIGILANT. In the long run, consumers benefit the most because a tougher FDA ensures that companies emphasize safety and efficacy in their clinical trials over financial pressures to introduce new medicines. No one can blame the drug industry for wanting to be as friendly as possible with the agency that oversees it. Each drugmaker is under the gun to put blockbuster drugs on the market in time to meet profit expectations. "The environment is ripe for the FDA getting back to its ultraclose relationship with Big Pharma, but that would be a mistake," says Lemuel Moye, associate professor at the University of Texas Health Science Center at Houston and a past FDA adviser.

Over the past several years, the vast majority of drugs approved by the FDA have turned out to be safe. Only a very few have been linked to fatal side effects in a small number of patients after approval. From a public-health perspective, however, the best stance the FDA can take is to stand vigilant and not hesitate to reject new-product applications or request more data when needed. With the policy stance the FDA seems to have taken this year, the public can rest easier that fewer dangerous drugs are likely to be placed on the market. Shook covers biotechnology for BW Online in New York


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