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October 18, 2011

Par Pharmaceuticals vs. FDA Calling for Truthful Speech vs. FDA Approved

Pharmaceutical sales
Last June, the United States Supreme Court, in a landmark decision, invalidated a Vermont law, which tried to restrict commercial speech of certain healthcare companies and stakeholders. 

In the IMS v. Sorell case, writing for the Majority, Justice Anthony Kennedy reasoned that, "Speech in aid of pharmaceutical marketing...is a form of expression protected by the Free Speech Clause of the First Amendment,” and as “a consequence, Vermont's statute must be subjected to heightened judicial scrutiny.”

In light of that decision, many legal and health policy authorities have begun to debate the impact of the IMS case on other areas of healthcare marketing and commercial speech.  Consequently, a recent case filed in the U.S. District Court for the District of Columbia, is likely to resolve this debate.

Par Pharmaceutical, Inc. v. FDA

The case, filed by Par Pharmaceutical, Inc. against the Food and Drug Administration (FDA), seeks declaratory judgment against the agency and 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. 

John Kamp, Executive Director of the Coalition for Healthcare Communication, who played a critical role in the IMS case, noted that, “Par's challenge goes directly to the heart of FDA's jurisdiction to censor truthful speech by drug sponsors.  After the Supreme Court decision in IMS, someone was bound to bring it. Now, the whole industry will be watching.”

The specific product in question is Megace ES, which is used for the treatment of anorexia (loss of appetite), cachexia (severe malnutrition), or unexplained, significant weight loss in patients diagnosed with AIDS (“wasting”). The brief filed by Par contains detailed information and cites scientific evidence about the use of Megace.  One particular piece of information stood out.

Specifically, Par acknowledged that the off-label use of megestrol acetate to treat wasting in cancer and geriatric patients is so widely accepted that “Par could not conduct placebo-controlled clinical trials that are the standard prerequisites to obtain FDA approval for a new use of an approved drug … because physicians would not agree to administer a placebo to cancer patients suffering from wasting, because the course of treatment would be contrary to the best interest of the patients, in light of the accepted off-label use of megestrol acetate.”

Par also noted that CMS subsidizes off-label use of Megace ES to treat wasting in non-AIDS cancer and geriatric patients and is “medically accepted” for off-label uses.

Legal Background

As noted by the brief filed by Par, FDA regulations provide that a pharmaceutical manufacturer commits a crime if it speaks to healthcare professionals about an FDA-approved prescription drug for a medical use that the FDA has not approved.  The government commonly refers to manufacturers’’ speech about unapproved uses of approved drugs as “off-label promotion.” 

However, these regulations do not limit or interfere with the authority of healthcare professionals to prescribe or administer any FDA-approved drug to any patient to treat any condition or disease.  As FDA explained in its Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical devices, “once a drug or medical device has been approved or cleared by DFA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regiments that are not included in the product’s approved labeling.”

Par asserted that FDA’s regulations also “purport to criminalize a manufacturer’s truthful and non-misleading speech about the FDA-approved uses of a prescription drug to physicians who may use the drug for approved uses but are more likely to use the drug for unapproved uses.

Based on these provisions, Par asserts that the “ongoing threat of prosecution for alleged ‘off-label promotion’ based on Par’s truthful and non-misleading speech to healthcare professionals concerning FDA-approved use of Par’s FDA-approved prescription drug currently chills Par’s speech.  The brief cites to numerous recent cases and settlements from the Department of Justice and Inspector General and various press releases, in which government officials reaffirm their prosecutorial passion for off-label promotion cases. 

Accordingly, Par filed suit, “seeking declaratory and injunctive relief to ensure its ability to engage in this protected speech free form the risk of criminal liability.”  Moreover, Par asserts that FDA’s regulations are “contrary to constitutional right” and “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” as applied to Par’s truthful and non-misleading speech to healthcare professions.

Specifically, Par argues that FDA and the government are interpreting the regulations “to prohibit a manufacturer from speaking to healthcare professionals about the FDA-approved, on-label uses of a prescription drug in a setting where physicians may prescribe the drug for both approved and unapproved uses.”

Moreover, Par points out that under FDA’s definition of “labeling,” it is unlawful for a manufacturer to provide any tangible materials (i.e. brochures, booklets, mailing pieces, etc.) to healthcare professionals containing manufacturer-supplied drug information if those materials prescribe, recommend, or suggest an unapproved use of an approved prescription drug.

Par explains how the FDCA provides that a drug’s “labeling” must bear “adequate directions for use” as long as the drug’s “label” repeats the doctor’s directions to a patient set forth in the prescription itself.  However, Par points out that an FDA regulation “nullifies this exemption by providing that a prescription drug’s labeling must bear “adequate directions for use” unless the label bears “adequate information for its use.”

FDA’s regulations define “adequate information” for a prescription drug’s use to mean directions under which medical professionals “can use the drug safely and for the purposes for which it is intended.”  Under the regulation, a drug’s “intended” uses are not limited to the uses set forth in its FDA-approved labeling, but rather encompass “all purposes for which [the drug] is advertised or represented.” 

If a manufacturer advertises or represents an approved prescription drug for an off-label use, the FDA’s regulation purports to require the manufacturer to provide “adequate directions” or “adequate information” for that off-label use in the drug’s labeling.   

However as Par pointed out, under these provisions, “a manufacturer cannot include directions or information for any off-label use in a drug’s “labeling,” or else the drug would constitute a “new drug” that cannot lawfully be sold.”  Thus, Par asserted that, “a prescription drug that is “advertised or represented” for an off-label use necessarily lacks “adequate directions” and “adequate information” for that off-label use.

Under FDA’s regulation, the drug is then automatically “misbranded” and liable for criminal violations.  Based on this reasoning, Par asserted that FDA’s regulation thus criminalizes the manufacturer’s truthful speech regarding a lawful, off-label use of an approved prescription drug.

Par also analyzed FDA’s regulation which defines a drug’s “intended uses” based on a manufacturer’s “objective intent,” which can be established based on the manufacturer’s “expressions” in any forum, including in “labeling claims, advertising matter, or oral or written statements.”  The manufacturer’s “objective intent” also can be established based on “circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.”

Under “the intended use” regulations, Par asserted that a manufacturer’s “speech concerning exclusively the FDA-approved, on-label uses of a prescription drug may demonstrate the manufacturer’s “objective intent” that the drug should be used for off-label purposes. 

For example, Par explained that, “if a manufacturer speaks about the on-label uses of a drug in a setting where physicians exercising independent medical judgment prescribe the drug off-label, the government interprets the FDA’s “intended use” regulations to require the manufacturer to provide “adequate directions” or “adequate information” for the off-label use in the drug’s labeling.

However, as Par recognized, “if the manufacturer made such a modification to a drug’s FDA-approved “labeling,” the drug would constitute a “new drug” that could not lawfully be sold under the FDCA.”  Accordingly, Par maintained that “when a manufacturer speaks about an on-label use of its drug in a medical facility where physciains prescribe the drug off-lable, the manufacturer is caught in a Catch-22: changing the drug’s labeling to add directions for the off-label use violates the Act’s criminal “new drug” rule, but based on the government’s view of the FDA’s “intended use” regulations, not changing the labeling to add those directions violates the Act’s criminal “misbranding” rule. 

The manufacturer’s “truthful speech about on-label use of its drug thus violates at least one of these criminal provisions.”

Discussion

As noted in Par’s brief, “once a drug is approved for marketing, FDA does not generally regulate how, and for what uses, physicians prescribe that drug,” and healthcare professionals may lawfully prescribe or administer an FDA-approved drug for uses that the FDA has not approved and thus are not included in the drug’s labeling.”

Par recognized that “many off-label uses of FDA-approved prescription drugs are widespread, medically accepted, and subsidized by the federal government under the Medicare and Medicaid programs. “  They further emphasized that in “some medical specialities, such as oncology, the majority of prescriptions are written for off-label uses of approved drugs.” 

Par also pointed to the fact that FDA itself has acknowledged that “in certain circumstances, off label uses of approved products are appropriate, rational, and accepted medical practice.”  They even cited to a statement from FDA Good Reprint Practices which clearly recognized that, “off-lable uses or treatment regimens may be important and may even constitute a medically recognized standard of care.”

Because of the “widespread, medically accepted, and government-subsidized off-label uses of numerous FDA-approved prescription drugs,” Par argued that it is “critical that healthcare professionals have access to accurate, comprehensive, and current information concerning off-label uses.”  Citing then-FDA Associate Commissioner for Health Affiars Stuart J. Nightingale, Par noted that the “principle for the FDA is that the very latest information that can be of value to physicians, pharmacists, and patients must be made available as soon as possible.” 

Conclusion

Given the Supreme Court’s recent decision in IMS and the explicit language they used to protect the commercial speech of healthcare stakeholders, Par may have a strong case.  For example, the majority in IMS noted that, “the fear that people would make bad decisions if given truthful information” cannot justify content-based burdens on speech.”  The Court added that, laws “may not burden protected expression in order to tilt public debate in a preferred direction,” and that ““fear that speech might persuade provides no lawful basis for quieting it.”

It should also be noted that a similar case, filed by the Washington Legal Foundation, is being considered in the Second Circuit already, which could lead to a quicker route to the Supreme Court if the cases were consolidated. 

While it will likely be years before this case reaches the Supreme Court, it still sends a strong message to FDA and the Obama Administration’s efforts at prosecuting off-label promotion, especially given last year, the DOJ, as part of a settlement, asked Allergan to drop a similar First Amendment claim.

It should be noted that if this case were to be decided in favor of Par and the industry, there is a possibility that the government would not appeal the case because if it were to make its way up to the Supreme Court and be decided in favor of industry, FDA and the Obama administration would have an extremely difficult precedent to overcome.

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