Risperdal is an atypical anti-psychotic drug that was approved by the FDA for the treatment of schizophrenia in 2002 and the treatment of acute mania and mixed episodes associated with Bipolar I disorder in 2003. Pursuant to the FDCA, physicians are allowed to prescribe drugs to patients for unapproved uses within the practice of medicine but the marketing or promoting a FDA-approved drug for indications other than those that are contained on the drug’s label, commonly known as off-label marketing, renders the drug misbranded in violation of federal law. In this case, the FDA alleged that, beginning in March 2002, JPI promoted Risperdal to health care providers for the treatment of agitation in elderly dementia patients and certain behavioral challenges in children, two uses for which Risperdal had not been proven safe and effective, and thereby misbranded the drug. Risperdal was not approved for any use in children until 2006 and has never been approved to treat dementia in the elderly.

In sum, in addition to its settlement agreements, JPI is subject to a corporate integrity agreement entered into with the Department of Health and Human Services as a way to prevent future fraud and abuse. If you have any questions about compliance with the FDA provisions involved in these recent settlements or other FDA laws and regulations pertaining to off-label marketing, please contact us at: contact@sglawfl.com.

The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA approves drugs for certain indications, or conditions, commonly known as intended uses. To be approved by the agency for a particular use, the drug sponsor must submit an application to the FDA demonstrating that the drug is safe and effective for the particular intended use.

Doctors commonly prescribe legally marketed drug products for indications not in the approved labeling, however. Botox Cosmetic, for example, was frequently used by doctors to treat crow’s feet prior to being approved for this intended use. This “off-label” use does not require approval by the FDA as long as the intent is the practice of medicine and the use is based on the doctor’s sound medical judgment. In comparison, the FDA typically prohibits the direct marketing of FDA-approved drugs for indications other than those included on the drug’s labeling. Accordingly, while such a limitation is not placed on physicians, the FDA prohibits drug sponsors and marketers of drug products from promoting products for intended uses other than those that are approved by the agency.

In sum, Botox Cosmetic is currently the only FDA-approved treatment for lateral canthal lines. In addition to treating canthal lines, Botox is also approved for several intended uses, including temporary improvement of glabellar lines (frown lines), treatment of chronic migraines, severe underarm sweating, blepharospasm (eyelid spasm) and strabismus (misalignment of the eyes).

More information about the FDA drug approval process can be found on the agency’s website. If you have any questions about the drug approval process or compliance with FDA regulations, please contact us at: contact@sglawfl.com.

Under the FDCA, the FDA approves drugs for certain indications, known as intended uses. In order for a specific use to be approved by the Agency, the drug sponsor must demonstrate that the drug is safe and effective for its intended use. 21 U.S.C. § 355. Once a drug is approved for a specific use, a doctor may prescribe such drugs for other uses based on his or her sound medical judgment. This practice, commonly referred to as “off-label use,” is a widespread and largely accepted practice, particularly because the regulation of the medical profession is left primarily to the states. As opposed to prescribing drugs for off-label uses, marketing FDA-approved drug products for indications other than those appearing in labeling is a practice that has come under fire by the FDA, with the Agency finding this practice tantamount to marketing an unapproved drug.

Returning to the Caronia case, the Second Circuit considered whether, given the protections of the First Amendment, it was constitutionally permissible to prosecute those engaged in pharmaceutical sales under the FDCA solely for promoting an FDA-approved drug for an off-label use. The Court noted that:

[w]hile the FDCA makes it a crime to misbrand or conspire to misbrand a drug, the statute and its accompanying regulations do not expressly prohibit or criminalize off-label promotion. Rather, the FDCA and FDA regulations reference “promotion” only as evidence of a drug’s intended use.

U.S. v. Caronia, No. 09-5006-cr, slip op. at 26 (2d Cir. December 3, 2012).

Accordingly, while the FDA argued that it did not prosecute Caronia for this off-label promotion and only considered the promotional statements as evidence of the charged violations of the FDCA, the Second Circuit disagreed. Rather, the Court found that the FDA relied solely on evidence of off-label promotion in targeting Caronia and that “[t]he government never suggested, for example, that Caronia conspired to place false or deficient labeling on a drug.” Id. at 29.

Further, because the Supreme Court has held that First Amendment Protections apply to speech in aid of pharmaceutical marketing, Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011), the Second Circuit explained that the government must be able to demonstrate that the:

(1) speech is not misleading and concerns lawful activity;

(2) government’s interest in restricting the speech in question is substantial;

(3) regulation directly advances the government’s interest being asserted,

and

(4) regulation is narrowly drawn in that it may be no more extensive than necessary to               serve the government’s interests.

Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 565-66 (1980) (emphasis added).

Applying this four-part test, the Second Circuit found that while the first two prongs of the test were “easily satisfied,” the FDA failed to satisfy the third and fourth prongs. Caronia at 42. In particular, the Court in Caronia found that off-label promotion is not in and of itself false and misleading or unlawful, and thus warrants protection under the First Amendment. Next, the Second Circuit found that the government’s interest in regulating in the area of drug safety and public healthcare is substantial. Id. On the other hand, the Court disagreed with the Agency’s position such regulation directly advances the government’s interests. Id. at 43-47. The Court based this finding on the fact that physicians are able to prescribe drugs for off-label uses, so the prohibition of statements by pharmaceutical manufacturers and sales representatives would only remotely serve the government’s interest in public safety. Finally, the Second Circuit found that the government’s regulation in this area is not narrowly drawn because there are various less-restrictive alternatives, such as informing the public in differentiating between false promotion and truthful information. Id. at 48.

Because the Agency’s interpretation of the FDCA led the FDA to prosecute Caronia solely based on statements about off-label use, without a finding that these statements were in fact false or misleading, the Court concluded that the Agency could have advanced its goals without restricting all speech in this area. In sum, the Second Circuit concluded that the government’s prohibition was overbroad and therefore found the criminalization of such speech to run afoul of the First Amendment.

For more information about off-label promotion of drugs and the FDA’s regulation of promotional speech, feel free to contact us at contact@sglawfl.com.

Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), the legislation enforced by the U.S. Food and Drug Administration (“FDA”), drugs are approved for specific uses, known as the “intended uses.” Under the FFDCA, pharmaceutical manufacturers and/or distributors may not market or otherwise represent their products for uses other than those approved by the FDA. While this practice, known as “off-label” marketing is forbidden, this is not to say that off-label use is also prohibited by the FFDCA. In fact, countless drugs are used for uses other than those approved in labeling. In the present case, because the FFDCA prohibits marketing of these uses, GlaxoSmithKline was targeted by the FDA for claiming that Paxil and Wellbutrin were beneficial in treating adolescents, a segment of the population for which the drugs were not approved.

In addition to off-label marketing prohibitions, manufacturers of pharmaceuticals are typically required to conduct post-marketing studies as a condition of approval. These studies are required in order to demonstrate the continued safety for consumers. With respect to GlaxoSmithKline , the Company allegedly failed to disclose data concerning the safety of its diabetes drug Avandia. Ultimately, this case illustrates that no matter how large and established, manufacturers must be diligent in their efforts to comply with federal laws and regulations or be prepared to face ample consequences.