By Frederick H. Fern and Kelly E. Jones Social Media...22 For The Defense November 2012 Frederick H. Fern, a registered pharmacist, is a member of Harris Beach PLLC in New York City

22 ■ For The Defense ■ November 2012

■ Frederick H. Fern, a registered pharmacist, is a member of Harris Beach PLLC in New York City and the leader of its Medical & Life Sciences Practice Group and a member of the DRI Drug and Medical Device Committee. Kelly E. Jones is a senior associate with Harris Beach PLLC and focuses her practice in New York and New Jersey on litigation and consulting involving FDA- regulated products. Ms. Jones serves on the steering committees for the DRI Drug and Medical Device and Young Lawyers Committees. A special thank you to Andre Major, a third-year law student at Brooklyn Law School, for his assistance with this article.

Fitting a Round Peg into a Square Hole FDA Off-Label

Promotion Rules in the World of Social Media

By Frederick H. Fern

and Kelly E. Jones

It is time for the FDA to rethink policy, as the prohibition on off-label marketing and the recent Guidance on responding to unsolicited requests for information do little to advance the agency’s mission to ensure that all drugs and devices are safe and effective.

The Food and Drug Administration (FDA) released new draft guidance on December 23, 2011, entitled, “Respond-ing to Unsolicited Requests for Off- Label Information about Prescription Drugs and Medical Devices.” The guid-

D r u g a n D M e D i c a l D e v i c e

© 2012 DRI. All rights reserved.

For The Defense ■ November 2012 ■ 23

ance advises how firms such as manufac-turers and distributors of pharmaceuticals and medical devices should respond to re-quests for information about unapproved or “off- label” uses for FDA- approved drugs and medical devices. The impetus for the guidance has been the continuing expan-sion and prevalence of the Internet and social media, and the industry’s resulting uncertainty regarding how to respond to information posted publicly and questions about off- label uses in light of the strict FDA ban on marketing for off- label indications.

Though the FDA has not yet finalized the guidance, in its current form it will do little

to resolve uncertainties. First, the guidance doesn’t clearly distinguish between solicited and unsolicited requests for off- label infor-mation and will chill the dissemination of valuable information about off- label uses. Second, the guidance unduly limits the per-mitted exchanges of valuable medical infor-mation that may adversely affect the public health. Finally, the guidance does not take into consideration the burgeoning case law, particularly the recent Supreme Court de-cision Sorrell v. IMS Health, which strongly suggests that the FDA ban on truthful mar-keting of off- label uses is an unconstitu-tional restriction of commercial speech.

BackgroundThe Food, Drug and Cosmetic Act (FDCA) prohibits manufacturers from marketing or promoting off- label drug uses. The FDA had interpreted a combination of provi-sions as effectively having made it illegal for manufacturers to disseminate information regarding indications for use that the FDA has not approved. The FDCA makes it ille-gal for a manufacturer to introduce a drug into interstate commerce unless the prod-uct has undergone clinical trials demon-strating safety and efficacy for its intended uses. See 21 U.S.C. §355(a), (b) (2006). Fur-thermore, the FDA must approve the label-ing of a new product for all of its intended uses; namely, the product’s directions for use, its indications, and its side effects. 21 U.S.C. §352(f) (2006). Moreover, the FDA interprets a manufacturer’s intended use by examining “labeling claims, advertis-ing matter, or oral or written statements by such persons or their representatives.” 21 C.F.R. §201 (2012).

Accordingly, if a manufacturer markets an approved drug for an indication not yet approved by the FDA, it “becomes an unap-proved new drug with respect to that use.” 65 Fed. Reg. 14,286 (2000). An unapproved new drug by definition would have insuf-ficient labeling and inadequate use direc-tions. See 21 U.S.C. §352(f) (2006); Wash. Legal Found. v. Friedman, 13 F. Supp. 2d 51, 54–55 (D.D.C. 1998). Consequently, a manufacturer must seek and obtain FDA approval for any new indication; other-wise any marketing of that off- label use is considered misbranding and violates the FDCA labeling mandates, regardless of the truthfulness of the information. See 21 U.S.C. §352 (2006); John E. Osborn, Can I Tell you the Truth? A Comparative Perspec-tive on Regulating Off- Label Scientific and Medical Information, Yale J. Health Pol’y & Ethics 299, 329 (2010). Violating the FDCA misbranding provisions also potentially subject violators to treble damages and qui tam actions under the False Claims Act (FCA) for “knowingly mak[ing], us[ing], or caus[ing] to be made or used, a false record or statement material to a false or fraudu-lent claim.” 31 U.S.C. §3729(a)(1)(B) (2006); Osborn, supra, at 310–11. Furthermore, any person convicted of illegally market-ing a drug is guilty of a misdemeanor. See 21 U.S.C. §331 (2006).

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While the FDCA serves nearly to ban off- label marketing absolutely, a physician has limitless ability to prescribe a medica-tion for an off- label use. Physicians have the absolute discretion to prescribe a medica-tion for any purpose that they deem med-ically appropriate, regardless of whether the FDA has approved the drug for that indication. Incongruity aside, this policy

acknowledges that completely banning off- label drug use is untenable because in many instances—particularly in pediat-rics and oncology—such off- label uses rep-resent novel and cutting- edge treatment for certain medical conditions. See Osborn, supra, at 303–04. It is widely accepted that the time- consuming and costly nature of the FDA approval process means that it is often economically unfeasible for a manu-facturer to test all potential off- label usages for a drug. See Anna B. Laakmann, Col-lapsing the Distinction Between Experi-mentation and Treatment in the Regulation of New Drugs, 62 Ala. L. Rev. 305, 317–18 (2011). Therefore, an outright ban on off- label usage would invade the province of the practice of medicine and in many instances prevent patients from receiving the best or only drug available for treating a medical condition.

Ostensibly, the FDA off- label use mar-keting ban seeks to prevent manufactur-ers from promoting off- label uses that have not endured the rigorous FDA screening process. Belying this justification, how-ever, the FDA has failed to distinguish between “truthful” and “misleading” off- label use marketing or to take into account

the unfettered discretion that physicians have to prescribe medication for off- label uses. Furthermore, as the Internet and social media have expanded and facilitated the spread of information, the FDA pol-icy on off- label use marketing has become increasingly unrealistic. It ignores that the public has wide access to informa-tion about off- label uses and widely seeks this information. See Susannah Fox, The Social Life of Health Information, Pew Internet & American Life Project 2 (May, 12 2011), http://pewinternet.org/~/media//files/reports /2011/pip_social_life_of_health_info.pdf. Accordingly, this policy is unsustain-able, as the recently released FDA guid-ance highlights in advising firms how to respond to unsolicited requests for infor-mation about off- label uses.

The FDA Draft GuidanceOn December 23, 2011, the FDA released a draft guidance document directed to the industry entitled, “Responding to Unso-licited Requests for Off- Label Informa-tion about Prescription Drugs and Medical Devices.” The FDA sought through the draft guidance “to describe the [FDA’s] current thinking about how manufac-turers and distributors… can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use.” U.S. Food and Drug Admin., Guidance for Industry Respond-ing to Unsolicited Requests for Off- Label Information about Prescription Drugs and Medical Devices, Draft Guidance, 1 (Dec. 2011), http://www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf. Specifically, the draft guid-ance explains how the FDA differentiates a solicited request for information from an unsolicited request and the proper proce-dures for responding to public and private unsolicited requests about off- label uses.

Solicited requests are those “requests for off- label information that are prompted in any way by a manufacturer or its repre-sentatives.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 5. A firm cannot solicit requests for information for off- label use, and the FDA may consider this evidence that the firm sought to mar-ket a medication for a new intended use in violation of the FDCA. See id. The draft guidance provides numerous examples of

solicited requests. For instance, the FDA would view a manufacturer’s sales rep-resentative mentioning an off- label use and inviting a health-care professional to request more information about the use as a solicited request. On the other hand, an unsolicited request is one “initiated by persons or entities that are completely independent of the relevant firm.” Id. at 4. Stated succinctly, a request for information is unsolicited when it was not “prompted in any way by [the] manufacturer or its repre-sentatives.” Id.

The draft guidance further subdivides unsolicited requests into public and non- public requests and defines each. Accord-ing to the draft guidance, “[a] non- public unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach.” Id. (mentioning an e-mail from an individual directed to the medical information staff of a manufacturer about an off- label use as an example of a private communication). A public unsolicited request is one “made in a public forum, whether directed to a firm specifically or to a forum at large.” Id. (mentioning posting a question about an off- label use of a specific product on a firm- controlled website or third-party forum accessible to a broad audience as an exam-ple of a public forum). The draft guidance then delineates the proper way to respond to each type of request.

The draft guidance lists the information that firms should include in all responses to non- public unsolicited requests about off- label uses. The FDA directs firms to answer unsolicited requests with “truth-ful, balanced, non- misleading, and non- promotional scientific or medical information that is responsive to the spe-cific request.” Id. at 6–7. Moreover, when a firm responds to a nonpublic request, the firm should distribute the information only to the person making the request “as a private, one-on-one communication,” and the information “should be tailored to answer only the specific question(s) asked.” Id. at 7 (indicating that if a firm receives a broad request the firm should narrow the response as much as possible). Further-more, information in a response should be “truthful” and “scientific in nature,” inde-pendent medical or scientific personnel should generate it, and publications that

As the Internet and social

media have expanded

and facilitated the spread

of information, the FDA

policy on off- label use

marketing has become

increasingly unrealistic.

For The Defense ■ November 2012 ■ 25

are contrary to or call into question the use at issue should accompany it. Id. at 8 (suggesting that to the greatest extent pos-sible firms should rely on “published peer- reviewed articles, medical texts, or data derived from independent sources”). As mentioned, a firm response to a nonpub-lic request should originate with medical or scientific personnel as opposed to sales or marketing personnel, and the following information should accompany it: a copy of the approved FDA labeling, a statement that the FDA has not approved the drug for the off- label use, a statement detailing the FDA- approved uses of the drug, a statement listing all important safety information, and a complete list of all references for the information disseminated in the response. Id. at 9 (also imposing a responsibility on the manufacturer to maintain records, particularly of the nature of the request for information, the information provided responding to the request, and follow- up questions received from the requestor).

The draft guidance makes a separate set of recommendations for responding to an unsolicited public request. Specifically, if the request for off- label information is made in a public forum, then a responding firm cannot respond in the same forum, which would then make the information available to the public and which the FDA would consider evidence of an intended off- label use. Id. at 10. (citing dual concerns that publicly posted information “is likely to be available to a broad audience for an indefinite period of time” and about the “enduring nature of detailed public online responses to off- label questions because specific drug or device information may become outdated). Furthermore, the draft guidance directs that firms should not respond to any public inquiry unless the request specifically refers to a product by name, and if a firm decides to respond publicly to such a request, the response should be limited to providing the manu-facturer’s contact information for the med-ical or science department and “should not include any off- label information.” Id. at 11 (emphasis in original). Finally, anytime a representative of a manufacturer responds to an unsolicited request, the representa-tive should disclose the involvement with the manufacturer and should refrain from adopting promotional tones. Id. at 12.

The Shortcomings of the FDA Draft GuidanceUnless the FDA makes major modifica-tions before finalization, the guidance as it stands will potentially increase uncer-tainty for drug manufacturers. Right now it doesn’t achieve its stated purpose: to “clarif[y] [the] FDA’s policies on unso-licited requests for off- label information, including those that firms may encoun-ter through emerging electronic media.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 1.

For example, two means by which the draft guidance differentiates a solicited request from an unsolicited request are troublesome. This is especially true given that firms cannot respond to unsolicited requests, and making a mistake distin-guishing between a solicited and an unso-licited request could elicit a violation. The draft guidance twice emphasizes that the FDA considers a request solicited if it is “prompted in any way by a manufacturer or its representatives.” Id. at 4, 5. This distinc-tion could potentially subject manufactur-ers to liability for a variety of innocent and widespread industry practices. For exam-ple, according to the broad language in the draft guidance, when a sales representa-tive asks a group of physicians if the physi-cians have any questions and one or more of those physicians respond with questions about off- label use, the FDA would consider this a solicited request. Technically, the sales representative’s question “prompted” the physicians’ inquiries. Moreover, if the FDA categorizes these inquiries as solic-ited, then the FDA might consider any response at all—even to convey truthful information or to offer the manufacturer’s contact information—evidence of promot-ing an off- label use. See id. at 4–5.

According to the draft guidance, the FDA will consider a request unsolicited only if it is “initiated by persons or entities that are completely independent of the [drug man-ufacturer].” Id. at 4. The FDA in the draft guidance does not clearly define “com-pletely independent.” While the draft guid-ance lists some of the medical professionals that the FDA may consider independent, it does not acknowledge that exceedingly commonly a drug manufacturer will have interactions with physicians or health-care organizations or recommend how a drug

manufacturer should interact with them. Id. For example, would the FDA view a phy-sician or a health-care organization as re-linquishing independence when they form purchasing or consulting agreements with a manufacturer? Moreover, if that physi-cian or organization suddenly becomes af-filiated with a drug manufacturer, would any question they asked about off- label us-

age become solicited, subjecting the manu-facturer to liability for responding?

These ambiguities regarding the dis-tinction between solicited and unsolic-ited requests can have a chilling effect on the dissemination of valuable medi-cal information. If a drug manufacturer is found to have promoted an off- label use illegally, it would potentially incur bil-lions of dollars in fines. For example, in July 2012, GlaxoSmithKline agreed to pay $3 billion to settle claims it illegally pro-moted off- label uses for Paxil and Well-butrin. Jesse J. Holland, GlaxoSmithKline to Pay $3 Billion for Health Fraud, S.F. Chron., July 2, 2012, http://www.sfgate.com/news/article/ GlaxoSmithKline-to-pay-3-billion-for-health-fraud-3678945.php (last visited Sept. 10, 2012). Because drug manufacturers poten-tially face massive penalties for off- label drug-use marketing, they will understand-ably err on the side of caution with ambigu-ous guidance activities which migh expose firms to those penalties. Inevitably health-care professionals will not have access to vital medical information that they should have access to, and their patients will not

Anytime a representative

of a manufacturer responds

to an unsolicited request,

the representative should

disclose the involvement

with the manufacturer

and should refrain from

adopting promotional tones.

26 ■ For The Defense ■ November 2012

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receive the most innovative treatments available for their medical conditions.

In addition to having a chilling effect, if adopted as it stands the FDA guidance also may unduly burden permissible exchanges of medical information. For example, ir-respective of the forum, a firm can only respond to a question about off- label infor-mation directly “to the individual making

the request… as a private, one-on-one com-munication.” U.S. Food and Drug Admin., Unsolicited Requests, supra, at 7. This ex-ample in the draft guidance illustrates the misguided nature of the policy regarding public requests for information: the FDA will classify a request as a public request when someone asks a manufacturer’s rep-resentative a question about an off- label use during a live presentation to multiple peo-ple. According to the draft guidance, any response must be “limited to providing the firm’s contact information and should not include any off- label information.” Id. at 11 (emphasis in original). Notably, this same scenario applies to most requests submitted through social media. If an individual posts a question about an off- label use in a public Internet forum, a response can only consist of the firm’s contact information. This pol-icy is counterproductive. By not responding to a direct question with a direct answer it appears that a firm has something to hide, and the inquiring health care professional cannot receive a prompt answer to a legiti-mate medical question.

Off-Label Marketing and the First AmendmentClearly some of the policies proposed by the FDA in the draft guidance regarding unso-

licited requests for off- label use informa-tion do not advance public health, but the general FDA policy on off- label marketing also may violate the First Amendment. His-torically, commercial speech was not con-sidered protected speech, but over the past 40 years commercial speech increasingly has garnered First Amendment protection. This trend began in 1976 with the Supreme Court decision that a Virginia law prohib-iting advertising prescription drug prices violated the First Amendment. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, Inc., 425 U.S. 748 (1976). Four years later, in Central Hudson Gas & Elec-tric Corp. v. Pub. Serv. Comm’n, the Court established a four-prong test for deter-mining whether particular commercial speech deserves First Amendment protec-tion from government regulation. 447 U.S. 557 (1980).

The test espoused in Central Hudson—still the controlling standard—first evalu-ates whether the speech promotes illegal activity or misleads. If so, the speech would not warrant protection. If the speech pro-motes legal activity and is truthful, then the second question a court asks is whether the restriction advances a substantial govern-ment interest. If a court determines that the restriction advances a substantial govern-ment interest, then a court would next ask whether “the regulation directly advances the government interest asserted.” Finally, the last prong asks “whether [the regula-tion] is not more extensive than is neces-sary to serve that interest.” Id. at 566. The government bears the burden of persua-sion for the final three prongs, and if the government does not meet the burden for all three, a court generally will find the reg-ulation unconstitutional. Coleen Klasmeir & Martin H. Redish, Off- Label Prescription Advertising, the FDA and the First Amend-ment: A Study in the Values of Commercial Speech Protection, 37 Am. J. L. and Med. 315, 338 (2011).

Under the Central Hudson framework, commercial speech has received expand-ing First Amendment protection. See, e.g., Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011); Thompson v. W. States Med. Ctr., 535 U.S. 357 (2002); Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001). The case law under the Central Hudson framework may support the proposition that the federal

ban on off- label drug-use marketing may be unconstitutional.

Under the first prong of the Central Hudson test, the commercial speech must promote lawful activity and be truthful to warrant First Amendment protection. Courts have held that off- label marketing satisfies this prong as long as the informa-tion disseminated is not inherently mis-leading because the underlying activity being promoted—off- label use of an FDA- approved drug—is lawful. United States v. Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y. 2008) (citing Wash. Legal Found. v. Fried-man, 13 F. Supp. 2d 51, 66–67 (D.D.C. 1998) (defining inherently misleading as “more likely to deceive the public than inform it”); United States v. Caputo, 288 F. Supp. 2d 912, 920–21 (N.D. Ill. 2003). Advertising is not inherently misleading because it promotes a particular point of view. The Supreme Court has stated that it is unlawful to ban truthful advertising that does not mislead simply because it has an effective sales pitch. See Sorrell, 131 S. Ct. at 2671; Liquo-rmart, Inc., 517 U.S. at 503 (“Bans on truth-ful, nonmisleading commercial speech… usually rest on the offensive assumption that the public will respond irrationally to the truth”). See also U.S. Food and Drug Admin., Unsolicited Requests, supra, at 10 (acknowledging that manufacturers are capable of responding to requests for off- label information in a “truthful, non- misleading, and accurate manner”).

Once a manufacturer demonstrates that the disseminated information is truthful, as mentioned the burden shifts to the gov-ernment to justify the commercial speech regulation. The first part of this burden, the second prong discussed in Central Hudson, requires the government to show that the regulation restricting commercial speech advances a substantial government inter-est. This is a relatively easy burden for the agency to satisfy, and courts have held that the FDA position that the ban encour-ages manufacturers to participate fully in the FDA regulatory process is sufficient. Thompson, 535 U.S. at 369–70 (holding that the government has a substantial govern-ment interest preserving the FDA new drug approval process). But cf. Friedman, 13 F. Supp. 2d at 69–71 (ensuring that physicians receive accurate and unbiased informa-tion does not qualify as a substantial gov-

Unless the FDA makes

major modifications before

finalization, the guidance

as it stands will potentially

increase uncertainty for

drug manufacturers.

For The Defense ■ November 2012 ■ 27

ernment interest); Klasmeir, supra, at 346. Consequently, a successful First Amend-ment challenge to the FDA ban on off- label drug-use marketing will likely have to demonstrate that the FDA has failed to sat-isfy the third or fourth prongs of the Cen-tral Hudson test or both prongs.

The third prong requires the FDA to show that the ban on off- label marketing directly advances the government interest asserted. Whether the FDA can satisfy this burden regarding off- label drug-use mar-keting is questionable even though current case law holds that an off- label market-ing ban does directly advance a substan-tial government interest in preserving the integrity of the FDA approval process. See Thompson, 535 U.S. at 371(finding that pro-hibiting advertising for products that have not undergone FDA screening may encour-age manufacturers to submit their prod-ucts to the testing process); Friedman, 13 F. Supp. 2d at 72 (determining that “one of the few mechanisms available to the FDA to compel manufacturers behavior is to con-strain their marketing options; i.e., control the labeling, advertising and marketing”). Accord Caronia, 576 F. Supp. 2d at 401.

However, as the third prong analyzes the asserted government interest, if the asserted interest encompasses the stated interest of protecting the public health, then the current FDA policy does not directly advance that interest. See U.S. Food and Drug Admin., Unsolicited Requests, supra, at 3. The FDA draft guidance acknowledges that “off- label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care” and that manufactur-ers often have the most complete informa-tion about a drug’s off- label use. See id. at 2. Consequently, a persuasive argument exists that current FDA policy has a detri-mental effect on the public health because firms cannot inform physicians about ther-apeutic off- label uses. Due to the FDA poli-cies limiting dissemination of information, patients may not receive the most innova-tive therapies for their conditions. See Klas-meir, supra, at 346. Accordingly, depending on the level of generality used to charac-terize its justification, the FDA draft guid-ance policies arguably does not satisfy the Central Hudson third prong because the policies prevent the dissemination of valu-

able information, which negatively affects the availability of helpful medical treat-ments. That the proposed policies articu-lated in the FDA draft guidance includes forbidding firms from publicly correcting untrue or misleading information about off- label drug uses further undermines that FDA-stated purpose to make helpful medi-cal treatments available. See U.S. Food and Drug Admin., Unsolicited Requests, supra, at 10–12.

The government must also satisfy the fourth prong of the Central Hudson test, whether a regulation is more restrictive than necessary to promote a substan-tial government interest. The government might have problems with this prong because current case law suggests that the prohibition on off- label drug-use marketing may not satisfy that burden. In Wash. Legal Found. v. Friedman, the court held that prohibiting the distribution of independent textbook excerpts and article reprints from medical and scientific journals concerning off- label drug uses was unconstitutional because the regulation was more extensive than was necessary to advance the sub-stantial government interest in encourag-ing manufacturers to submit all drug uses to the FDA for approval. 13 F. Supp. 2d 51, 54–55 (D.D.C. 1998) vacating as moot, Wash. Legal Found. V. Henney, 202 F.3d 331 (D.C. Cir. 2000) (vacating the district court judgment after the FDA adopted the position that the Food and Drug Adminis-tration Modernization Act and the guid-ance at issue did not confer authority to the FDA to prohibit or to sanction speech). Importantly, the district court held that the FDA had less restrictive means available to achieve the substantial government inter-est of encouraging manufacturers to sub-mit all drug uses to the FDA for approval that would not burden commercial speech; namely, the “full complete, and unambig-uous disclosure by the manufacturer,” in-cluding a disclaimer that the FDA had not approved the off- label use. Id. at 72–73. But see United States v. Caronia, 576 F. Supp. 2d 385, 397 (E.D.N.Y. 2008) (holding that the off- label marketing ban was constitutional partly because the court could not “iden-tify non-speech restrictions that would likely constrain in any effective way manu-facturers from circumventing the approval process”). Despite the different reason-

ing articulated by the court in Caronia, 576 F. Supp. 2d at 397, the Friedman court instructively reasoned that full disclosure rather than regulation “comports with the Supreme Court’s preference for combating potentially problematic speech with more speech.” 13 F. Supp. 2d at 73.

Subsequently, the Supreme Court has indicated a strong reluctance to condone regulations that burden commercial speech when the government has other means of regulation available. In Thompson v. W. States Med. Ctr., the Supreme Court held that a law that prohibited pharmacies from advertising compounded drugs was uncon-stitutional. 535 U.S. 357 (2002). The Court determined that the law did not satisfy the forth prong of the Central Hudson test because “the Government… failed to dem-onstrate that the speech restrictions [were] not more extensive than [was] necessary to serve those interests.” Id. at 371 (internal citations omitted). Specifically, the Court suggested that the government could adopt acceptable alternatives to a commercial speech restriction such as limiting the vol-ume of compounded drugs that a phar-macy could sell or limiting the percentage of total revenue that compounded drug sales could account for. Id. at 372. The FDA potentially could also adopt these measures as less restrictive alternatives to the current FDA ban on off- label drug-use marketing.

In Sorrell v. IMS Health, the U.S. Supreme Court determined that the First Amend-ment is hostile toward any regulation that places restrictions on commercial speech in the name of the public good. Sorrell held that a Vermont law that prevented pharma-cies from selling prescription information to pharmaceutical companies for market-ing purposes violated the First Amendment because it did not directly advance the state interest in protecting medical privacy and reducing health-care costs. Sorrell, 131 S. Ct. at 2668. The Court declared that “[s]peech in aid of pharmaceutical market-ing… is a form of expression protected by the Free Speech Clause of the First Amend-ment.” Id. at 2659. Specifically the Court wrote that “[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.” Id. at 2670. (finding fault addi-

Off-Label , continued on page 81

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tionally with the law because it restricted the availability of information that many people find very helpful) (internal citations and quote marks omitted).

The federal ban on off- label drug-use marketing is analogous to the Vermont law that the U.S. Supreme Court found uncon-stitutional: at its most basic level, the FDA has prohibited commercial speech, off- label drug-use marketing, without regard for its truthfulness, out of concern that it would un-duly persuade the public to make bad deci-sions. This concern is not a valid justification for restricting commercial speech because “[t]he choice ‘between the dangers of sup-pressing information, and the dangers of its misuse if it is freely available’ is one that ‘the

First Amendment makes for us.’” Id. at 2671 (quoting Va. State Bd. of Pharmacy, 425 U.S. at 770). Accord Thompson, 535 U.S. at 375. Furthermore, since the FDA probably could achieve the narrowly stated goal of encour-aging manufacturers to seek approval for all indications through less restrictive means, the regulation and policies articulated in the FDA draft guidance may only await a con-stitutional challenge by a manufacturer on First Amendment grounds.

ConclusionThe FDA’s stated mission is to ensure that all drugs and devices are safe and effective. This is a noble goal which no drug manu-facturer, physician, or patient could find fault with. However, the FDA’s prohibition

Off-Label , from page 27 on off- label marketing and the recent Guid-ance clarifying its policy on responding to unsolicited requests for off- label informa-tion do little to advance that goal. The net result of recent policy announcements will be that drug manufacturers are too con-strained and fearful to provide truthful and valuable information about off- label uses, even in the limited instances when the Guidance provides an opportunity to do so. Consequently, doctors may not be fully informed and patients may not receive the latest innovative therapies. It is time for the FDA to rethink their policy towards off- label marketing, and recent First Amend-ment jurisprudence suggests the courts may be willing to do it for them upon the appropriate challenge.