Here's a lift from SH, thanks to Di7026.
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NOVEMBER 14, 2002
NEWS ANALYSIS :TECH
The FDA's Big...Free-Speech Challenge?
The agency's rules severely restrict what companies can say about their products. Those rules, however, may be in for a major revision
When word got out that Medtronic Inc. (MDT ) was working on a product that could quell a rare form of severe nausea, patients began clamoring for more details. But the Minneapolis medical-device maker couldn't tell them anything. The Food & Drug Administration prohibits companies from talking about products before the agency approves them, for fear that patients' hopes could be dashed if the claims didn't hold up.
According to court documents recently unsealed in a Massachusetts whistleblower case, drugmaker Parke-Davis (now a division of Pfizer [PFE ]) put profits ahead of the public health by deliberately breaking FDA rules against promoting unapproved uses for drugs. Parke-Davis got FDA approval for its drug, Neurontin, for a very narrow use -- as an add-on treatment in some cases of epilepsy.
But the whistleblower lawsuit alleges that Parke-Davis boosted sales by illegally marketing the drug for pain, anxiety, depression, and other more lucrative uses. The drugmaker even wrote articles on how Neurontin worked for the larger uses and paid scientists to "author" the papers and publish them in professional journals. Subsequent studies suggest the drug may not be effective for those uses.
CHALLENGE NO. 1. These stories illustrate the two sides in the fight over a company's right to talk about its products. And now, the FDA, in a landmark reexamination of its approach to the advertising and marketing of food, drugs, and medical devices, is putting the issue up for debate.
Stung by losses in court, in May the agency invited anyone to comment on its rules, which govern everything from how much fine print has to be included in drug ads to what health claims can be made for breakfast cereal. With the comment period now over, the reevaluation is shaping up as one of the first major controversies that will confront Dr. Mark B. McClellan, the highly regarded former Stanford University health economist who's the Bush Administration's nominee for FDA commissioner.
What seems like an intractable dispute, however, could actually be an important opportunity for the FDA to revamp its rules, thus allowing it to spend less time on minutiae and refocus on fighting real abuses. "The FDA's purpose is to protect the public health, but they've become the federal nanny," gripes Washington lawyer Richard L. Frank. But McClellan will have to assuage the fears of consumer advocates, who worry that any new freedoms the FDA allows industry could undermine the agency's ability to protect the public.
"EXCESSIVE PROHIBITION"? The debate largely centers on the doctrine of commercial free speech. Traditionally, the FDA -- with considerable support from Congress -- has held that the dangers of misinformation are great enough that it needs to restrict what food, drug, medical-device, and some other types of companies can say about their products. But the agency has come under fire from companies and commercial free-speech advocates for infringing on their First Amendment rights.
Advocates of commercial free speech argue that people would benefit by getting more information from companies. "The FDA has been guilty of excessive prohibition of speech," says Richard A. Samp, chief counsel of the Washington Legal Foundation, which has filed several lawsuits challenging the agency's ban on promoting unapproved uses. Adds Medtronic Senior Counsel Robert Kelpinski: "This government protectionism just isn't the American way. It should fall down with the Iron Curtain."
Consumer groups, however, are philosophically opposed to granting more freedom to industry, fearing that the financial pressures on companies are so great that commercial free speech is rarely fully truthful. They -- and even some FDA staffers -- also fear that the deck is stacked in the agency's current reevaluation effort, which is being led by its powerful chief counsel, Daniel E. Troy.
LITTLE CHOICE. Before joining the FDA a year ago, Troy was a prominent advocate of commercial free speech at the Washington law firm of Wiley Rein & Fielding. Judging from the way Troy is handling the request for comments, "It appears that the Bush Administration is trying to undermine the agency's ability to regulate claims for drugs and other products," says Larry D. Sasich of the Public Citizen Health Research Group.
Troy declined to comment for this story, but people close to him say he scoffs at the notion. Several court losses over the past three years have left the agency with little choice but to reevaluate its policies, one top FDA official says. And as long as it cracks down on false or misleading claims, as top officials insist they will, the public won't be put at risk.
Congressional watchdogs will be quick to jump on the FDA if they think it's allowing industry too much freedom. This is such a big issue for them that it was the first Senator Edward Kennedy (D-Mass.) raised when he questioned McClellan at his confirmation hearing. McClellan said that the agency is committed to enforcing its rules. But he added that, according to the Supreme Court, "the FDA may have overstepped."
A NEW RIGHT. McClellan clearly has a point. From the 1930s to the early 1970s, Congress gave the FDA broad powers to regulate food, drugs, and devices to protect people from unsafe or ineffective products. Those powers include curbing promotional activities until a drug has gone through the agency's rigorous approval process. If companies could advertise uses for their products that the FDA hasn't approved, the theory goes, they would have little incentive to apply for FDA approval for those products and uses -- and the public would never know for sure if the products really work.
However, the courts began to recognize a new right of commercial free speech. In Central Hudson Gas & Electric Corp v. Public Service Commission of New York (1980), the Supreme Court said the government can restrict even truthful speech -- but only when the government has a substantial interest, such as getting products submitted for approval, and then only if it has no other means of achieving the same goal.
This Central Hudson test was the downfall for the FDA in the most recent key case, Thompson v. Western States Medical Center. In a 5-4 vote in April, the Supreme Court ruled that a ban on advertising drugs mixed by pharmacists violated the First Amendment because the agency didn't prove it had no alternatives to the ban. "If the First Amendment means anything, it means that regulating speech must be a last -- not first -- resort," the court said.
SHIFTING BURDEN. Now, the FDA is in a legal bind. While the ban the court struck down was very narrow, "the logic and the issue place the FDA in what appears to be a pretty vulnerable position," explains Washington attorney David G. Adams, a former top FDA lawyer. Take FDA restrictions on promoting unapproved uses for drugs. The goal is to get companies to do new trials and submit applications to the agency for those new uses, so that doctors and patients know if the drugs actually work. But if there are other ways to prove that the drugs work for other uses, then the restrictions are unconstitutional.
None of this threatens the FDA's power to crack down on the really bad guys. "The fundamental thing we do is ensure the information is not false and misleading," explains a top official. "These cases did not limit our ability to do that." But the danger is that burden of proof in thousands of mundane cases will shift, and the agency will have to prove that companies aren't telling the truth.
"The FDA does not want to go down that road, because the resources needed would be enormous," says Francis B. Palumbo, director of the Center on Drugs & Public Policy at the University of Maryland School of Pharmacy.
GOOD TREND. The first step in finding a middle ground is constructing a watertight definition of the government's interest in restricting speech, FDA experts say. Agency lawyers could even argue for new justification, such as protecting the public health.
At the same time, Troy is already limiting enforcement actions to those he's sure the agency could defend in court and is giving industry more freedom in the gray areas of advertising and promotion, FDA watchers say.
That's probably a good trend. In foods, the agency has no need to always dictate the exact words for health claims or warnings. And ditching the almost unreadable full page of medication side effects known as the "brief summary" and allowing more readable information instead can only help the public.
No one expects a marketing free-for-all. Companies actually like FDA oversight because it gives them much-needed credibility. But for every change, expect a bruising fight as commercial free speech advocates and their opponents argue about what's better for the public's health. |
