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What's Wrong With The FDA

FDA Suffers Second Massive Legal Defeat in "Pearson vs. Shalala II

May 2001

By William Faloon

FDA dragged into Court again


In Pearson II, Durk Pearson, Sandy Shaw and the other Pearson plaintiffs returned to federal court to force FDA to comply with Pearson I by allowing the plaintiffs’ folic acid claim to enter the marketplace immediately. The Court granted the plaintiffs request for a preliminary injunction to the extent that it declared FDA’s action unconstitutional. The Court held that “FDA acted unconstitutionally, and particularly in violation of the Court of Appeals decision in [Pearson I], in suppressing Plaintiffs’ claim rather than proposing a clarifying disclaimer to accompany the Claim.” FDA has sixty days to implement the decision but, rather than do that, it has asked the Court to reconsider its ruling, another delaying tactic.

Pearson II is a particularly bitter defeat for FDA because it comes at the hands of the very judge who ruled in favor of FDA in the case reversed by Pearson I: Judge Gladys Kessler of the U.S. District Court for the District of Columbia. At oral argument before she ruled in Pearson II, Judge Kessler explained that she had been persuaded that her earlier decision had been incorrect. She said that she believed that the Court of Appeals’ decision in Pearson I was the proper resolution of the matter. She then issued a very well-reasoned decision that constitutional law experts who have studied the case believe will be very hard, if not impossible, for FDA to appeal successfully.

If FDA does file an appeal, it will face the same Court that denied FDA’s request for rehearing of Pearson I by 11 to 0.

In Pearson II, Judge Kessler rejected FDA’s arguments one by one. She found FDA’s failure to comply with the Pearson I order inexcusable, writing, “there is no question that the agency has acted with less than reasonable speed in this case; for example, it waited for more than 18 months before revoking rules declared unconstitutional by the Court of Appeals.” She found it “clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson.” She stated that “the agency appears to have at best, misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals Opinion.” She found that “FDA has continually refused to authorize the disclaimers suggested by the Court of Appeals—or any disclaimer, for that matter” and “has simply failed to adequately consider the teachings of Pearson: that the agency must shoulder a very heavy burden if it seeks to totally ban a particular health claim.”

In granting the injunction against FDA’s decision to prohibit the folic acid claim, Judge Kessler found, “FDA’s decision… was arbitrary, capricious and an abuse of discretion.” She thought it “very clear that Plaintiffs are harmed by the FDA’s suppression of the Folic Acid Claim,” explaining that the continued violation of their First Amendment rights constituted “irreparable harm.”

FDA loses case against compounding pharmacies on First Amendment grounds

Most Americans don't know that they can legally obtain certain drugs that are not FDA-approved at compounding pharmacies. The cost of these “compounded” drugs is often lower than what it costs to buy finished drugs made by pharmaceutical companies. The reason most Americans don't know about drugs available at compounding pharmacies is that up till now, the FDA said it was “illegal” for compounding pharmacies to promote the drugs they offered.

A Federal appellate court has just ruled that the FDA cannot restrict advertising by pharmacists who sell compounded drugs. The decision pitted the free speech rights of pharmacists against a Federal law aimed at restricting advertising of compounds that require a doctor's prescription, but aren't subject to the FDA's approval process.

In citing previous cases, the U.S. Court of Appeals for the Ninth Circuit Court (San Francisco) stated that “government prohibitions of truthful commercial messages are ‘particularly dangerous' and deserve ‘rigorous review.’”

In this case, the FDA contended that restrictions on ads for compounds were an attempt to balance the needs of individual patients with the protection of the broader public by “preventing widespread distribution of compounded drugs.”

In an opinion (that upheld a lower court ruling), Judge Cynthia Holcomb Hall wrote that “the government neither explains nor supports” its contention that wider distribution of compounded drugs would endanger the public. “In fact, most of the evidence runs to the contrary,” she wrote, noting that “compounding is not only legal under state law, but most states require their pharmacists to know how to compound.”

Judge Hall went on to say that the government offered “no evidence demonstrating that its restrictions would succeed in striking the balance it claims is a substantial interest, or even protect the public health.”

Two years ago, the FDA lost a similar case when they challenged the right of drug company representatives to promote the use of approved drugs for uses that were not approved by the FDA. In both of these cases, the FDA was trying to censor the promotion of a legal activity. Since both drug compounding and using approved drugs for unapproved uses is legal, the FDA did not have a right to ban it, so say the Courts.

The FDA expended considerable tax dollar litigating these losing cases. It is difficult to ascertain what “consumer protection” benefit the FDA expected to attain if they had prevailed in these expensive court actions.

Judge says FDA’s position “Harmed the public interest”

Indeed, Judge Kessler found the FDA’s suppression of the claim inexcusable not only because it deprived the Plaintiffs of their “rights to effectively communicate. . . health message[s] to consumers” but also because it harmed the public interest. FDA’s existing, allowed folic acid claims convey the false and misleading impression that folate in unfortified foods is effective in reducing neural tube defects when, in fact, it has never been proven effective. The only source of folic acid proven effective is synthetic, i.e. the kind of folic acid found in supplements. The only amounts shown to reduce neural tube defects consistently and reliably are above 400 mcg, with 800 mcg regarded as an ideal dose by many leading scientists. The only large-scale placebo controlled clinical trial corroborating a 100% reduction in neural tube defects in women with no prior history of neural tube defect births involved use of dietary supplements containing 800 mcg a day of folic acid (“Prevention of the first occurrence of neural-tube defects by periconceptional vitamin supplementation,” New England Journal of Medicine 1992 Dec 24; 327(26):1832-5). The FDA rejected this study, but Judge Kessler did not. She ruled FDA’s rejection of the study an abuse of discretion, finding the need for the information substantial. Here is what the Judge said:

“The public health risk from neural tube defects (NTD) is undeniably substantial. NTDs occur in approximately 1 of every 1,000 live births in the United States. Approximately 2,500 babies are born every year with an NTD. Of the children born with NTDs, most do not survive into adulthood, and those who do experience severe handicaps. The lifetime health costs associated with spina bifida, the most common NTD, exceed $500,000, and the yearly costs in Social Security payments exceed $82 million.
“Given that the scientific consensus, even as acknowledged by the FDA, confirms that taking folic acid substantially reduces a woman’s risk of giving birth to an infant with a neural tube defect, the public interest is well served by permitting information about the folic acid/NTD connection to reach as wide a public audience as possible. Plaintiffs’ Folic Acid Claim… communicates this vitally important message.”

Is the FDA now in contempt of court?

Pearson II and Pearson I have profound implications for FDA’s regulation of health information. These decisions establish beyond any legal doubt that the FDA must comply with the First Amendment. Those decisions make it clear that FDA cannot suppress health information on the basis that the agency disagrees with the message communicated. Instead, FDA must be in the business of fostering the dissemination of health information to the public, not censoring it.

Although the Pearson I and II decisions concern dietary supplements, they rest on broad First Amendment doctrines that are the supreme law of the land and have greater authority than any FDA regulation. As a consequence, the Pearson decisions are likely to cause the toppling of FDA’s censorship of food and drug claims over time. If applied to their full extent, the First Amendment principles of Pearson mean that FDA has no constitutional power to prevent the public from receiving any truthful and nonmisleading health information about any product that agency regulates.

Those principles mean that FDA must rely on corrective disclaimers, whenever possible, as an alternative to its current practice of censorship. The days of FDA censorship are destined to come to an end. For the moment, however, the agency still (even after Pearson II) continues to censor health claims for supplements, health claims for foods and off-label claims for drugs. That would appear to be contempt of court. In one case now pending before the United States Court of Appeals involving FDA suppression of a vitamin B6, vitamin B12, folic acid and vascular disease claim, plaintiffs represented by attorney Jonathan Emord have asked the U.S. District Court to hold FDA in contempt for its noncompliance with the Pearson decision. It may well be that in due time FDA and its officers will be made to account personally for FDA’s unlawful refusal to comply with the First Amendment.