Sorrell vs. IMS Health: FDA’s Ban on Truthful Off Label Promotion May be Vulnerable
A recent panel of health lawyers discussed the Supreme Court decision in IMS v. Sorrell and further assessed the impact of the decision on marketing regulation.
Richard M. Cooper, a partner at Williams & Connolly, noted that, “the most important recent development in First Amendment law is the Supreme Court’s decision in Sorrell v. IMS Health, Inc., where the Court struck down a Vermont statute that prohibited pharmaceutical companies from using individual prescriber information in detailing to physicians.” An article from the Food and Drug Law Institute (FDLI) recently summarized the panel.
In light of that decision, a recent case filed in the U.S. District Court for the District of Columbia, by Par Pharmaceutical, Inc. against the Food and Drug Administration (FDA), seeks declaratory judgment against the agency. Par asserts the First Amendment and the Federal Food, Drug and Cosmetic Act (FDCA) bar application of certain regulations that FDA purport to criminalize Par’s “truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of its FDA-approved prescription drug.”
As a result, they ask that the court invalidate the applicable FDA regulations and certain definitions and declare that a “manufacturer cannot be deemed to intend an off-label use merely because the manufacturer sells a drug with knowledge that physicians will prescribe the drug for an off-label use.
The expert panel included: Harvey A. Ashman, Senior Vice President, General Counsel and External Affairs, IMS Health; Diane E. Bieri, Senior Vice President and General Counsel, PhRMA; and Bert W. Rein, Founding Partner, Wiley Rein LLP. John F. Kamp. PhD, Executive Director, Coalition for Healthcare Communication, served as moderator.
Sorrell Discussion
Cooper concluded that the Court’s determination that “in the fields of medicine and public health, . …information can save lives,” was a “ringing endorsement of First Amendment protection of truthful, non-misleading detailing.” Cooper said that this language provides arguments for invalidating FDA’s prohibition of truthful, non-misleading, off-label promotion.
Cooper explained that many passages in the opinion can be applied to off-label uses. For example, the Court reiterated its holding in Thompson v. Western States Medical Center that “fear that people would make bad decisions if given truthful information’ cannot justify content-based burdens on speech.”
The Court referred to “the government’s legitimate interest in protecting consumers from commercial harms.” But Cooper stated that it is hard to think of any harms other than bad decisions, from truthful, non-misleading off-label promotion.
Cooper asserted that, “FDA’s only defense for the ban on off-label promotion is the incentive it creates for manufacturers to file supplemental applications for approval or clearance of additional uses.” But approved drugs and approved or cleared devices promoted off-label have already been through an approval/ clearance process, and the question arises whether they must go through the same process again and again for each additional use.
He said that if FDA’s ban on off-label promotions is viewed as a restriction on speech subject to heightened scrutiny, it may be vulnerable for five reasons:
- “The ban is on truthful, non-misleading statements about a lawful use of a lawfully available product, as to which there is a strong public interest in the circulation of truthful, non-misleading information.”
- The volume of information about off-label uses available from speakers other than manufacturers, suggests that the incentive to file supplements is “relatively ineffective.”
- Physicians contemplating prescribing a drug for an off-label use can take into account the presence or absence of FDA’s imprimatur together with peer-reviewed literature and other information.
- Banning truthful, non-misleading speech to induce participation in a lengthy review process is questionable under First Amendment procedural jurisprudence, particularly because there is a hefty fee. In addition, once a manufacturer submits a supplement, the incentive has worked, the interest in protecting FDA’s approval process would seem to be preserved, and a continued ban on promotion of that off-label use seems unjustified.
- FDA could use less drastic means such as disclosures and warnings, require that supplements be filed when estimated off-label use reaches a specific level or other specified conditions are met. Or, FDA could restrict the quantity of a product that may be shipped so that the product would be limited to distribution only for its approved uses.
Expert Panel’s Take on Sorrell
Ashman was pleased that the Court was not confused by the technology involved and recognized that information saves lives. He was also pleased that the paternalistic limit on information will not be accepted for physicians who are experts.
Rein focused on the fact that the Court applied a heightened scrutiny standard, rather than the rational basis test usually applied in administrative law cases. He said that food and drug lawyers have to become constitutional lawyers. This is an “information driven business,” he explained, and anything that prescribes or limits information “has a First Amendment overlay.”
Bieri said that industry won a lot because the Court recognized that “an effective market is not evil.” She also said that physicians who want to hear about products from manufacturers also won. Bieri stressed the importance of providing information
to physicians , noting that “they need to be refreshed and taught about new uses for existing products.” The dialogue from industry is one way of educating doctors.
Cooper also discussed a number of other cases involving First Amendment and off-label marketing challenges similar to Sorrell.
Medical Product Manufacturer’s Citizens Petition
Cooper discussed the petition filed by seven medical product manufacturers on July 5 asking FDA to clarify its policies and regulations regarding the dissemination of information relating to new uses of marketed drugs and medical devices. Specifically, the petition seeks clarification on four topics:
1) manufacturer responses to unsolicited requests for information about off-label uses;
2) the concept of ‘scientific exchange” in 21 C.F.R. § 312.7;
3) interactions with formulary committees, payers, and similar entities; and
4) the dissemination of clinical practice guidelines issued by third parties.
United States v. Catonia
Cooper said that a key case to follow is an appeal to the Second Circuit in the Catonia case. Alfred Catonia is a pharmaceutical salesman who was convicted of conspiring with others to introduce a misbranded drug into interstate commerce. The government argues that the crime of introducing a misbranded drug into commerce is not a charge involving speech, but rather conduct.
The government claims that Catonia’s off-label promotion while detailing a doctor is merely evidence of a drug’s intended use. Under the government’s theory, intended use relates to the subjective intent in the minds of regulated firms and their employees.
Cooper disagreed with this theory, stating that “intended use is a matter not of subjective intent, but of what FDA’s regulations (21 C.F.R.§§ 201.128 and 801.4) call “objective intent.”
Beeman v. Anthem Prescription Management, LLC
Last July, a divided Ninth Circuit panel upheld a California law against a first amendment challenge; the law was previously found to be unconstitutional by three decisions at the intermediate level. The law requires pharmacy benefit managers to conduct or otherwise obtain studies of retail drug prices paid by uninsured private customers and to report the results to their third-party-payer clients.
The court held that the law did not chill, limit, or burden any speech by the PBM and did not prevent them from conveying to their clients any messages they wanted to convey. The court also stated that “the government may not prohibit speakers from disseminating facts.” Cooper stated “Of course, the ban on off-label promotion often does exactly that.”
Tobacco Control Act
Cooper said that the outcome of a suit filed by the tobacco industry in the Western District of Kentucky may shed some light on the status of the ban on off-label promotion. The cigarette manufacturers challenged the Tobacco Control Acts’ provision
barring product manufacturers from making any reduced risk claim for a tobacco product without prior FDA approval. Cooper said that this is structurally similar to the ban on off-label promotion of a drug or device:
- The product is already on the market lawfully
- The ban applies to speech that is truthful and not misleading
- The ban discriminates as to speakers and content in that anyone else can say whatever they want about the relative risk of different tobacco products.
The Use of the Threat of Exclusion to Suppress Speech
Cooper was particularly disturbed by the fact that companies under criminal investigation for off-label promotion cannot risk defending a criminal prosecution in court and asserting a First Amendment right to engage in such promotion. Cooper explained
that “a mere indictment creates a risk of permissive exclusion from federal healthcare programs; conviction of certain offenses results in mandatory exclusion.”
Because of the broad coverage of Medicare, Medicaid, veteran’s healthcare, and other federal healthcare programs, “exclusion is a corporate death sentence.” That is why companies pay huge sums – in many cases hundreds of millions of dollars and even more than billion in some cases – to settle criminal investigations of off-label promotion