FDA labeling

Friday, September 13, 2002

Like many other federal agencies, the Food and Drug Administration has found itself mired in many commercial-speech controversies. Ever since Congress passed the Food and Drugs Act in 1906, the government has possessed the authority to regulate pharmaceuticals.

Controversies involving the FDA usually occur when the manufacturer or retailer of a drug wishes to advertise its product. The FDA often rigidly monitors such ads to ensure that they accurately inform the public on issues directly affecting health and safety.

Examples of recent controversies include the advertising of compounded drugs, the content of labels on dietary supplements and the advertising of so-called off-label uses of approved drugs.

Advertising of compounded drugs
In 2002, the U.S. Supreme Court examined whether restrictions on the advertising of compounded drugs violated the First Amendment. Compounding is a process in which a pharmacist combines or mixes ingredients to create or modify a medication that meets a patient’s specific needs.

The Food and Drug Modernization Act of 1997 exempts compounded drugs from the standard approval process imposed by the Food and Drug Administration. However, the act imposes certain advertising restrictions with respect to compounded drugs. The law says drug providers may not promote or advertise particular compounded drugs, though they may advertise the fact that they compound drugs in general.

In 1998, eight pharmacies from seven states sued in federal court, contending that the advertising restrictions violated their First Amendment rights. The FDA countered that some pharmacists were offering compounded drugs to avoid FDA drug requirements.

In 2002, the Supreme Court sided with the pharmacies in Thompson v. Western States Medical Center by a vote of 5-4. The high court applied the standard test applied to restrictions on commercial speech — the Central Hudson test from the Court’s 1980 decision in Central Hudson Gas & Elec. Corp. v. Public Serv. Comm’n of N.Y.

The Central Hudson test provides that the government may regulate commercial speech that concerns unlawful activity or is misleading. If the speech passes this threshold requirement, the government may only regulate the speech if the government (1) has a substantial interest in its regulation; (2) the regulation directly and materially advances the government’s interests; and (3) the regulation is narrowly drawn.

In Thompson,the government did not argue that the speech concerned unlawful activity or was misleading. Instead, the government argued that it satisfied the remaining prongs of the Central Hudson test.

The government contended that it had three substantial interests in prohibiting the advertising of compounded drugs. The government defined these interests as: (1) “preserving the effectiveness and integrity of the FDA’s new drug approval process and the protection of public health it provides”; (2) “preserving the availability of compounded drugs for those individual patients who, for particularized medical reasons, cannot use commercially available products that have been approved by the FDA”; and (3) “achieving a proper balance between these two independently compelling but competing interests.”

The Supreme Court agreed the government had substantial interests in regulating the ads, noting that “the Government needs to be able to draw a line between small-scale compounding and large-scale drug manufacturing.”

However, the Court also concluded that the federal law did not pass the final two prongs of the Central Hudson test. The Court determined that the government’s restrictions on the advertising of compounded drugs were too broad.

“We have made clear that if the Government could achieve its interests in a manner that does not restrict speech, or that restricts less speech, the Government must do so,” the Court wrote. The majority mentioned “several non-speech-related means” that the government could use without restricting advertising, including: banning the use of commercial-scale manufacturing; limiting the amount of compounded drugs in general; capping the amount of any particular compounded drug; or limiting compounding to situations in which a patient has a prescription.

The Court also reasoned that the effect of the law would be to prohibit too much “beneficial speech,” writing:

For example, a pharmacist serving a children’s hospital where many patients are unable to swallow pills would be prevented from telling the children’s doctors about a new development in compounding that allowed a drug that was previously available only in pill form to be administered another way.

Labels on dietary supplements
The FDA has faced lawsuits over the labeling of dietary supplements. In a leading case, Pearson v. Shalala, the U.S. Circuit Court of Appeals for the District of Columbia determined that the FDA violated the First Amendment rights of dietary-supplement marketers by refusing to allow them to make certain health claims on their products’ labels. The marketers wished to make the following four claims on their supplements:

  1. “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.
  2. “Consumption of fiber may reduce the risk of colorectal cancer.
  3. “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
  4. “.8mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.”

The FDA would not allow the marketers to make these statements on the labels. The FDA argued that the claims could not be made because there was no “significant scientific agreement” as to the merits of the statements.

However, according to the D.C. Circuit, “the FDA never explained just how it measured ‘significant’ or otherwise defined the phrase.” The appeals court also reasoned that even if the statements did not have “significant scientific agreement,” the government could have furthered its own interests in a less speech-restrictive way — by requiring disclaimers instead of outright bans on speech.

The federal appeals court noted that the U.S. Supreme Court “has reaffirmed this principle, repeatedly pointing to disclaimers as constitutionally preferable to outright suppression [of speech].”

“It is clear, then, that when government chooses a policy of suppression over disclosure — at least where there is no showing that disclosure would not suffice to cure misleadingness — government disregards a ‘far less restrictive’ means,” the court wrote.

The government also argued that the First Amendment rights of dietary-supplement manufacturers were not infringed because the manufacturers could still make their claims in published articles and books. The appeals court rejected that argument, writing that “those channels of communication reach consumers less effectively than does a claim made directly on the label because they impose higher costs on consumers.”

Off-label drug uses
The FDA also has been involved in First Amendment controversies relating to off-label uses of approved drugs. Off-label use means using a drug in a way different from the stated method on the label, such as administering a medicine at a new dosage, through a new route (oral or intravenous) or for a new indication, as detailed by legal commentator Shane Ward.

The FDA has restricted product sponsors from advertising off-label uses of drugs. However, a federal district court judge ruled in Washington Legal Foundation v. Friedman that off-label use materials were a form of commercial speech protected by the First Amendment. The D.C. Circuit affirmed the ruling but did not reach the First Amendment issue because on appeal the FDA conceded that it did not have the legal authority to regulate speech about off-label use. The appeals court wrote: “We certainly do not criticize the reasoning or conclusions of the district court. As we have made clear, we do not reach the merits of the district court’s First Amendment holdings, and part of its injunction still stands.”

Ward wrote that “although the First Amendment issue was not reached by the circuit court, the case retains its constitutional significance.” This means that when the FDA regulates the use of off-label materials, the First Amendment comes into play.

These cases show that the FDA has found itself embroiled in several controversies regarding the advertising of health products. Even though the FDA has great authority over this area, the First Amendment prohibits wholesale speech restrictions without meeting constitutional standards.