The year 2001 brought two significant victories for free-speech advocates in their continuing battle with the Food and Drug Administration.  In Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), the U.S. Court of Appeals for the Ninth Circuit struck down a portion of the Food and Drug Administration Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, 111 Stat. 2296 (1997). The court found that 21 U.S.C. Secs. 353a(a) and (c) imposed unconstitutional restrictions on the speech rights of pharmacists who compound prescription drugs. 

     Additionally, in Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001), the U.S. District Court for the District of Columbia held that the FDA’s refusal to authorize a folic acid health claim proposed by dietary supplement designers, sellers, and manufacturers violated the First Amendment.

     In Western States Medical Center v. FDA, the Ninth Circuit held that certain FDAMA subsections (codified at 21 U.S.C. Secs. 353a(a) and (c)) that prohibited pharmacists from promoting and advertising particular compounded drugs violated the First Amendment.  Compounding is a process that pharmacists employ to mix ingredients to create, for individual patients, medications that are not otherwise commercially available.  FDAMA exempted compounding from specified requirements of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. Sec. 321 et seq., on the condition that compounding pharmacies comply with certain restrictions -- including a prohibition on the advertising and promotion of compounded drugs. 

     On appeal, the Ninth Circuit invalidated 21 U.S.C. Sec. 353a in its entirety, agreeing with the district court’s conclusion that the challenged advertising restrictions violated the First Amendment, but disagreeing that the invalid sections could be severed from the remainder of 21 U.S.C. 353a. 

     The court analyzed subsections 353a(a) and (c) under the well-established test for government regulation of commercial speech set forth in Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980).  The prohibited speech satisfied Central Hudson’s first prong because it concerned a lawful activity (compounding drugs) and was not inherently misleading.  The government made no contrary contention, and the court found “no indication in the record that [pharmacists’] advertisements are untruthful.”  Western States, 238 F.3d at 1093.

     The court then found that only two of the three interests asserted by the government were “substantial” within the meaning of Central Hudson’s second prong.  The government asserted three interests in restricting the speech in question: (1) protecting public health and safety; (2) preserving the integrity of the drug approval process; and (3) balancing the need to preserve drug compounding for individual patients having particularized needs against preventing widespread distribution of compounded drugs.  While the court agreed that the first two interests were substantial, it found the third interest lacking.

     According to the court, balancing competing goals can be a substantial governmental interest only if the government provides “a compelling argument or convincing evidence that it has a substantial interest in achieving both goals.”  Id. at 1094.  However, the government failed to supply sufficient evidence of its substantial interest in preventing widespread compounding (and, in fact, the weight of evidence showed that compounding was not only legal but required by most state laws).  Thus, the court held that the government failed to demonstrate a substantial interest in balancing the need to preserve drug compounding against the need to prevent the widespread distribution of compounded drugs.

     Considering Central Hudson’s third prong, the court found that the restrictions on the pharmacists’ speech did not “directly advance” the government’s substantial interests.  With regard to the government’s interest in protecting public health, the court found that the government had failed to explain adequately why restricting the advertisement of compounded drugs would reduce the consumption of such drugs in the limited circumstances where such drugs are harmful.  The Ninth Circuit criticized as speculative the government’s claim that advertising restrictions would protect unwary consumers by keeping demand for particular compounded drugs artificially low.  Further, the court explained that existing safeguards -- other than the challenged advertising restrictions -- adequately protect the public against the distribution of unsafe compounded drugs. 

     With regard to the government’s second stated interest, the court found that FDAMA contained so many exceptions to the advertising restrictions that the restrictions themselves could not advance the government’s interest in maintaining the integrity of the drug approval process.  For instance, FDAMA allows pharmacists to promote compounding as long as they do not promote a particular compounded drug, and provides significant incentives for pharmacists to increase their drug compounding business.  Relying on Greater New Orleans Broadcasting Association v. United States, 527 U.S. 173 (1999), and Rubin v. Coors Brewing Co., 514 U.S. 476 (1995), the court concluded: “When exemptions and inconsistencies counteract the alleged purpose of a speech restriction, the restriction fails the direct advancement test.”  Western States, 238 F.3d at 1095.

     The court also found that the challenged speech restrictions failed Central Hudson’s fourth prong because the government ignored less-restrictive means it could have employed to advance its asserted interests.  According to the court, the legislature could have required pharmacists to include disclaimers on their compounded drugs stating that the drugs had not been approved by the FDA and that they had not been subjected to a complete safety review by the agency.  Even if the district court had not proposed that the FDA require disclaimers on compounded drugs, “prohibitions on truthful speech are still strongly disfavored,” and “[t]he First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good,” the court said.  Id. at 1096.

     The court then ruled that the constitutionally offensive subsections could not be severed from the remainder of FDAMA.  The legislative history, which indicated that FDAMA was designed to strike a balance between compounding and manufacturing, overcame the presumption of severability created by FDCA’s general severability clause.  Id. at 1097-98.  Accordingly, the Ninth Circuit invalidated 21 U.S.C. Sec. 353a in its entirety.

     The last chapter on Western States Medical Center has yet to be written.  The U.S. Supreme Court granted the government’s petition for a writ of certiorari and agreed to hear the case.  Oral argument took place on Feb. 26, 2002, and a decision is expected later in the year.

     In another food and drug law opinion issued in 2001, the U.S. District Court for the District of Columbia awarded a preliminary victory to dietary supplement designers, sellers, and manufacturers who have been seeking -- since 1994 -- FDA approval of a certain folic acid health claim.  On remand from Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (Pearson I), the agency had refused to authorize the plaintiffs’ proposed folic acid claim -- even with clarifying disclaimers -- based on its determination that the claim was “inherently misleading” and thus not entitled to First Amendment protection. 

     The plaintiffs responded by filing suit, claiming that the FDA’s actions violated the First Amendment.  In Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C. 2001) (Pearson II), the district court agreed that the agency violated the First Amendment by refusing to consider disclaimers to accompany the proposed claims. 

     The district court held that the FDA’s refusal to authorize the plaintiffs’ folic acid claim, or to propose a disclaimer to accompany the claim, violated the First Amendment and that plaintiffs were entitled to preliminary injunctive relief.  The court found that the plaintiffs were substantially likely to succeed on the merits of their argument because the agency failed to satisfy the test for regulating commercial speech set forth in Central Hudson.  Applying Central Hudson, the court determined that  the FDA failed the test’s final prong by employing a method of regulation (namely, total suppression of speech) that was more restrictive than necessary. 

     To reach this conclusion, the court first rejected the FDA’s determination that the plaintiffs’ folic acid claim was “inherently misleading.”  According to the court, “the mere absence of significant evidence in support of a particular claim does not translate into negative evidence against it,” and the studies that the agency relied upon could not be accurately described as contrary to the plaintiffs’ proposed claim.  Id. at 115.  Therefore the court determined, as a matter of law, that the plaintiffs’ proposed claim was not “inherently misleading,” but rather only “potentially misleading.”  Id.

     Continuing with the Central Hudson analysis, the court found that the government had a substantial interest in the “protection of public health and prevention of consumer fraud,” and that the FDA’s regulation of health claims on dietary supplements directly advanced this interest.  Id. at 113.  However, the FDA’s regulation violated the First Amendment because the agency’s chosen method of regulation was more restrictive than necessary.  Id. at 113-14. 

     According to the court, the FDA steadfastly refused to consider the disclaimers suggested by Pearson I, or any other disclaimers for that matter, choosing instead to suppress the plaintiffs’ speech outright.  Id. at 114.  Citing Pearson I, the district court concluded 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.’”  Id. at 113.   

     The court concluded that the “FDA’s determination that the Folic Acid Claim is ‘inherently misleading’ and cannot be cured by disclaimers is arbitrary and capricious,” and that the plaintiffs had demonstrated a substantial likelihood of success on the merits.  Id. at 118-19.

     The district court next found that the plaintiffs had demonstrated that they suffered real harm by the FDA’s suppression of their proposed claim.  Relying on Elrod v. Burns, 427 U.S. 347, 373 (1976), the court observed: “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”  Pearson II, 130 F. Supp. 2d at 119. 

     Then, the court determined that the threatened injury to the plaintiffs outweighed the threatened harm that the injunction would have on the defendants and third parties.  According to the court, “even if Plaintiffs’ Folic Acid Claim is in some respects ‘potentially misleading,’ the resulting injury that could flow to consumers cannot compare, as a matter of law, with the First Amendment injury Plaintiffs have continually borne in the two years since Pearson was decided.”  Id.    

     Finally, the court found that granting the injunction would serve the public interest in two important ways.  First, “it is clearly in the public interest to ensure that governmental agencies, such as the FDA, fully comply with the law.”  Id. at 119.  Second, it facilitated dissemination of the plaintiffs’ folic acid claim, which “regardless of whether it is ideally worded or entirely free from misleadingness,” communicates a vitally important message about the connection between folic acid and the prevention of neural tube disorders.  Id. at 120.

     Accordingly, the court held that the FDA’s refusal to authorize the plaintiffs’ folic acid claim violated the First Amendment and must be preliminarily enjoined.  The court then remanded the case to the FDA, “instructing the agency to draft one or more appropriately short, succinct, and accurate alternative disclaimers, which may be chosen by Plaintiffs to accompany their Folic Acid Claim.”  Id. at 121.

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     Western States Medical Center and Pearson II provide assurance that the courts will continue to hold the FDA to strict First Amendment standards: The FDA will not be permitted to act as though the First Amendment does not apply to its actions.  No longer, it appears, will the agency be allowed to employ blanket speech restrictions when less restrictive alternatives, such as disclaimers, are available.  The FDA’s continued -- albeit recent and judicially mandated -- subjection to the First Amendment should facilitate the dissemination of vital health information to physicians and consumers, although the information may be accompanied by FDA disclaimers.