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FDA on the ropes: is it gatekeeper or jailer?

Posted by elliott on 10/15/02 at 19:59 (097573)

The article below is from today's New York Times:


October 15, 2002
Stung by Courts, F.D.A. Rethinks Its Rules

After losing a series of court decisions that found it in violation of the First Amendment's guarantee of freedom of speech, the Food and Drug Administration has begun a wide-ranging review of regulations that control what the makers of drugs, supplements, food and cosmetics can say about their products.

At issue is the delicate balance between a company's right to communicate with its customers and the food and drug agency's mandate to protect the public.

But the court decisions, which included a stinging rebuke from the Supreme Court in April, have prompted the agency to ask whether it may, at times, have gone too far in its insistence that it decides when scientific truth has been established and what companies can say. At issue are regulations governing everything from what a drug company can print on a T-shirt to what a sales representative can say in the privacy of a doctor's office.

No one is advocating that false or inaccurate claims be permitted. But agency officials are asking questions like whether they can continue to prevent food companies from making health claims for their products and whether they can continue to insist that drug advertising include a full accounting of side effects and conditions that may make the drug inadvisable.

The review began with a notice in The Federal Register on May 16 inviting interested parties to comment on 'First Amendment issues.' Hundreds replied, with wish lists, cries of alarm, hefty documents from drug company lawyers and notes from consumers who want the agency to take all shackles off the supplement industry. The comment period ended on Sept. 13, and those who wish to respond to comments have until Oct. 28.

Over the next few months the agency will review the comments and decide what changes, if any, to propose in its regulations. It also expects to get a new commissioner, Dr. Mark B. McClellan, who was nominated by President Bush late last month and seems headed for a speedy confirmation. 'No decision will be made without his involvement and approval,' said Daniel Troy, the agency's chief counsel.

The review is not just an academic exercise, warns Dr. David A. Kessler, who was the agency's commissioner from 1990 to 1997.

'It represents a frontal attack on the fundamental responsibilities of the agency under the Food, Drug and Cosmetic Act,' said Dr. Kessler, who is now the dean of Yale's School of Medicine. 'I have great concerns that this is simply an attempt to deregulate while doing it in the name of the First Amendment.'

Others say the review is long overdue.

Jonathan Emord, a lawyer who sued the F.D.A. on behalf of the First Amendment rights of supplement manufacturers and won, says the the agency has long been treading on shaky legal ground.

'We are advocating that the F.D.A. undergo a change in regulatory mind-set, a First Amendment sensitivity training,' Mr. Emord said. 'They take the position that science must be interpreted for the public and given to them piecemeal when the regulators decide it is proven. That role of being a gatekeeper is precisely what the First Amendment was designed to prevent.'

Until now, the agency's position has been that it decides what companies can say and how they can say it. Its mission of protecting the public health, the agency argued, gives it broad authority to regulate commercial speech.

But Mr. Troy says recent court rulings have given the agency pause.

On April 29, the Supreme Court bluntly informed the agency that it was being overly paternalistic.

The question before the court was whether pharmacies that made specialized mixtures of prescription drugs could advertise or promote their products. Mr. Troy, arguing for the F.D.A., said that if pharmacies were allowed to do so they would essentially be selling prescription drugs without demonstrating safety and efficacy.

'Why spend the millions of dollars to come through our approval process?' Mr. Troy asked. 'It's our fundamental power to approve drugs before they come on the market.'

But the Supreme Court said that restricting free speech should be a last resort, writing, 'We have previously rejected the notion that the government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.'

Two other rulings by lower courts rebuked the agency on similar grounds. In 1998, the Federal District Court for the District of Columbia overturned F.D.A. regulations preventing companies from freely distributing information about unapproved uses for approved drugs and devices. (The agency's challengers were represented by Mr. Troy, a constitutional lawyer who was in private practice before coming to the F.D.A. in 2001.)

The court said it was not enough for the agency to argue that it was protecting the public. 'To the extent that the F.D.A. is endeavoring to keep information from physicians out of concern that they will misuse that information,' the federal court said, 'the regulation is wholly and completely unsupportable.' The decision was vacated on appeal.

Another ruling, in 1999, involved the F.D.A.'s refusal to allow dietary supplement makers to put four health claims on their labels. The agency said the claims failed its test of 'significant scientific agreement.' But the United State Court of Appeals for the District of Columbia Circuit held that the First Amendment requires a 'preference for disclosure over outright suppression.'

With this background, Mr. Troy remarked, 'some have said that it would be almost legal malpractice if we did not think about the implications of the First Amendment decisions that came down recently.'

He added, 'As a lawyer, my job is to prevent the agency from being sued, and losing.'

In comments to the F.D.A., many companies said regulations were needed to protect the public health, but asked that some of the current ones be relaxed.

Dr. Rhona Applebaum, executive vice president for scientific and regulatory affairs at the National Food Processors Association, describes agency regulations as 'command and control.'

Dr. Applebaum added: 'The way it stands now, any type of implied disease benefit, the agency throws it into our faces: 'No, you can't do it. You need a new drug approval.' We're saying no way, not if the information we are providing is substantiated by science.'

For example, Dr. Applebaum said, many studies suggest that dietary calcium is associated with lower blood pressure. But the F.D.A. does not find the evidence conclusive. Food manufacturers would be happy to put in disclaimers, she said. 'You could say, 'While inconclusive, new research seems to indicate . . .' or 'Preliminary evidence suggests that calcium promotes healthy blood pressure.' But right now we can't say it.'

Manufacturers of drugs and medical devices request more leeway in distributing articles on new uses of their products. Once a drug or medical device is approved for one use, doctors can use it for any other purpose, at their discretion. But the F.D.A. says that if a company distributes articles on unapproved uses of a product, that is tantamount to promoting it.

Boston Scientific, which makes medical devices, questioned those regulations. Tony Blank, the company's manager of corporate regulatory affairs, said the company could not even provide a published paper on the risks of using one of its devices in an unapproved way.

'When it becomes most concerning is when the information the company wants to provide has additional warnings to protect the patient,' Mr. Blank said.

Dr. Kessler, the former F.D.A. commissioner, says that such arguments may sound reasonable, but adds that articles may be technically accurate but not true.

'Let's say there are 100 studies on a drug and one of those studies says the drug has an effect on cancer,' Dr. Kessler said. 'Ninety-nine studies show the drug does not have such effects. It is a accurate statement that a study has found that the drug affects tumors. But it is not true.'

That is why, Dr. Kessler said, the F.D.A. insists on evaluating all the relevant scientific data. It is the reason for its regulations on what can be on food and drug labels, what companies can say about drugs and medical devices that are not yet approved for marketing, what they can say about unapproved uses for their products and what they can say when they advertise drugs to consumers.

The concern that the statements be true, not just accurate, he said, is why the agency 'requires companies and the agency to look at all the data and base their statements not on whether something is technically accurate but whether it is supported by the weight of the evidence.'

Some, like David Vladeck, a lawyer who heads the litigation group for Public Citizen, a consumer advocacy group, say that there are real questions here, but that does not mean the answer is to deregulate.

'Given the resources that the agency and the industry have devoted to this issue, I would be astonished if nothing comes of it,' Mr. Vladeck said. 'I know Dan Troy. He's a bright and engaging guy. But he's not just spinning his wheels.'

But Mr. Troy said he was merely opening to the public what might otherwise be a private discussion within the agency. 'The irony is, some who criticize us for doing it are in favor of public participation,' he said. 'The further irony is, It is not as if these questions would go away if we didn't ask them. We would just have to wrestle with them within the agency.'