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Specifically, the FDA announced it was seeking public comment on whether any of its existing regulations or policies violate the First Amendment. Given the response from some quarters, one would think the FDA's proposal was tantamount to closing up shop.
The FDA's move to consider the constitutional implications of its own regulations was long overdue. A string of recent Supreme Court cases have made clear that so-called commercial speech, including advertising, promotional efforts, and product labels, is protected by the First Amendment. Just this April, in Thompson v. Western States Medical Center, the Court struck down portions of the Food and Drug Administration Modernization Act of 1997 restricting the advertisement and promotion of so-called compounded drugs — drugs created by pharmacists by combining or mixing active ingredients from approved medicines to tailor a drug to the needs of a specific patient. Federal law barred pharmacists from advertising or otherwise promoting compounded drugs to doctors or patients. In an opinion by Justice Sandra Day O'Connor, the Court found these rules to be unconstitutional limits on protected speech. In response to the Western States Medical Center opinion, on May 16 the FDA published a notice in the Federal Register "seeking public comment to ensure that its regulations, guidances, policies, and practices continue to comply with the governing First Amendment case law." The notice made clear that the FDA had no intention of giving up all regulation of pharmaceutical advertising and promotion. "To be sure," the notice stated, "FDA will continue to regulate commercial speech as part of its mandate." At the same time, the notice made clear that the FDA would consider modifying existing rules where necessary to survive judicial scrutiny. The compounded drug rules were not the first FDA policies to be struck down on First Amendment grounds and, if the FDA does not reevaluate some of its current policies, they are unlikely to be the last. Following the FDA announcement, defenders of the regulatory status quo warned that consideration of constitutional claims could "gut" public health protections. Naderites fretted that in the FDA's hands the First Amendment would become a "license to practice quackery." Writing in the Washington Post, two former FDA officials claimed the agency "placed public health protections in jeopardy" by considering the constitutional limits of its authority "for the first time." According to these former bureaucrats, the FDA's decision was "a direct outgrowth of a movement led by conservative judges, academics and advocacy groups" that now threatened to undermine "common-sense assumptions" about the government's role in regulating information about foods, drugs, and medical devices. As much as some government officials and regulatory advocates hate to admit it, commercial speech is covered by the First Amendment. Advertising, product labels, and other forms of economic expression may not receive the same level of protection as core political speech, but they are protected nonetheless. So long as the speech in question concerns lawful activity and is not misleading, government may only impose restrictions where necessary to advance a "substantial" governmental interest. To meet constitutional muster, the regulation must directly advance the asserted interest, and cannot be more extensive than is necessary. As the Court explained in Western States Medical Center, even where a governmental interest is substantial, "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." Thus, the federal government may not prohibit advertising or promotion where mandated labels or disclosure requirements will do. In the words of the Court: "If the First Amendment means anything, it means that regulating speech must be a last — not first — resort." The First Amendment obviously limits the ability of federal agencies to control advertising, product promotions, and labels — just as it inhibits other well-intentioned initiatives in other policy spheres — but it hardly spells the end of such regulation altogether. In its recent Federal Register notice, the FDA made clear it merely sought to ensure that existing regulations comply with the constitutional standard. Such a move may be "unusual" in modern-day D.C., as the Washington Post noted, but it hardly amounts to a radical plot or sinister threat to public health. Critics of the FDA's announcement suggest that loosening the reins on commercial speech inevitably helps corporations at the expense of physicians and their patients. This is an unsustainable position. Speech restrictions, like the FDA's drug approval process, can harm public health as much as help it. Drug company advertising may encourage consumers to seek prescription drugs more often than necessary, but it is also an effective means of educating consumers about health conditions, and medications, about which they were previously unaware. In the case of compounded drugs, for example, the FDA's regulations would have prevented pharmacists from informing physicians about tailor-made compounds for patients with special needs. One use of compounding is to make medications taste better so they are easier to give to children. Only the most paternalistic among us believe that the public welfare is served by barring the dissemination of such truthful information to consumers — yet that has been a premise of FDA regulation for years. If anything places "public health protections in jeopardy" it is the FDA's past refusal to consider potential constitutional limitations on its authority (something of which Congress is guilty as well). By seeking public comment on existing programs, the FDA will be able ensure that its policies and regulations comply with constitutional requirements and are able to survive the inevitable legal challenges. In other instances, the FDA will be forced to find alternative means to fulfill its regulatory mandate without infringing on the free flow of truthful commercial information. This may well mean an end to regulation-as-usual at the FDA, but it is hardly something to fear. Indeed, the FDA's decision to consider the First Amendment "for the first time" is not nearly as shocking as the fact that it took federal officials so long to consider the Constitution at all. — Jonathan H. Adler is an assistant professor at the Case Western Reserve University School of Law. |
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the Constitution a threat to public health? Some regulatory advocates
and former government officials think so. Earlier this month the Food
and Drug Administration (FDA) suggested that some of its own policies
or regulations might be unconstitutional. 
