In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”) has been particularly aggressive in using the False Claims Act to pursue recoveries from individuals, health care providers, and drug manufacturers that participate in federal health benefit programs. In fact, from 2009 to 2016, DOJ collected $19.3 billion from health care False Claims Act settlements and judgments, with $2.5 billion recovered in fiscal year 2016, alone. (More DOJ false claims statistics can be found here.) DOJ’s enforcement efforts are not solely targeted against garden variety billing fraud, but also involve claims arising from alleged violations of health care regulatory requirements. Among other things, the DOJ has been targeting claims for reimbursement for off-label uses of regulated products. DOJ’s aggressive policy of holding manufacturers accountable for off-label claims under the False Claims Act is entirely consistent with FDA’s stance on off-label communications as described in the January memo. However, recent court interpretations of off-label communications as protected First Amendment speech, as well as interpretations of the causality component of False Claims Act claims, have apparently caused DOJ to reconsider its strategy with respect to such cases. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue describing how FDA’s regulatory scheme has persisted in light of the key First Amendment decisions involving off-label promotion. Even though FDA hesitated in and ultimately rejected promulgating regulations that would make any action “that directly or indirectly suggests to the physician or to the patient that an approved drug may properly be used for unapproved uses for which it is neither labeled nor advertised” (37 Fed. Reg. 16,503, 16,504) into a matter warranting enforcement action, the Agency used this reasoning to shape an off-label communication policy. As I described in Part 2, FDA’s policy enjoyed some support from federal courts; however, this support was only temporary. More recently, federal courts have shown support for the idea that truthful and non-misleading promotions of off-label uses of drugs and devices by manufacturers are protected under the First Amendment. A review of the pivotal cases in this area will help put FDA’s off-label policy in perspective, especially in light of FDA’s reaction to these cases in a memorandum published in January 2017. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

As 2017 began, FDA appeared poised to implement significant changes to the rules governing off-label communications related to drugs, biologics, and medical devices. The Agency had hosted a public hearing in November 2016 to receive input from interested industry stakeholders and members of the public about possible alternatives for off-label regulation, seemingly a first step in exploring more liberal (or possibly stricter) enforcement standards.  However, in January, FDA released a new final rule amending the definitions of “intended use” applicable to drugs and devices in 21 C.F.R. §§ 201.128, 801.4, which would affect how off-label uses are considered with respect to intended use of regulated products, and issued a memo discussing its current position on off-label uses and communications.  In short, all of FDA’s actions since the November public hearing have shown that it intends to continue strict enforcement of off-label promotion despite changes in the highest levels of government and strongly negative industry response. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 1

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications.  Although the Agency has for years resisted calls to loosen its long-standing prohibitions on the off-label promotion of unapproved products, it has simultaneously recognized that truthful and non-misleading scientific or medical information coming from manufacturers about their own drug, biologic, and device products plays an important role in the U.S. health care system.  This has especially been true in a climate where individual products are becoming more complex; precision medicine approaches to treating disease are gaining ground in clinical practice; and the health system is evolving into one more focused on outcomes and value-based arrangements between entities.  The expansion of First Amendment commercial speech principles by the courts over the past decade and lawsuits against FDA also have pushed the Agency to move towards the potential reform of its existing off-label policies.   Continue Reading Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

Open Pill BottleTimes, They Are A-Changin’

On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including pharmaceutical and medical device companies, doctors, patients, research institutions, health care organizations, and payors and insurers, regarding the appropriate regulation of manufacturers’ communications about off-label uses for their marketed medical products. Medical products include prescription drugs, biologics, medical devices, and animal drugs. This public meeting was originally “teased” by Agency officials as far back as April 2015, so it has been highly anticipated by all interested stakeholders. FDA’s announcement also comes after a series of high-profile losses for the Agency and the DOJ in the government’s attempt to prohibit and criminalize truthful, non-misleading off-label marketing. Continue Reading FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”) Yates Memo.  Last week, another Massachusetts federal court jury acquitted two more former health care executives of felony charges following another closely watched post-Yates-Memo prosecution.  This time, the jury found William Facteau, the former CEO of Acclarent, and Patrick Fabian, Acclarent’s former Vice President of Sales, not guilty of 14 counts of felony fraud related to Acclarent’s off-label promotion of a medical device (although the jury did find them guilty of related misdemeanor charges). Continue Reading Another Jury Acquits in One of the First Few Prosecutions of Health Care Executives Following DOJ’s Yates Memo

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to treat Amarin’s proposed truthful and non-misleading off-label marketing about its drug, Vascepa (icosapent ethyl), as violative of the Food, Drug, and Cosmetic Act (“FDCA”). In August of last year, the Court ruled that FDA was impermissibly chilling truthful speech in violation of the First Amendment. Amarin Pharma, Inc. v. FDA, 2015 U.S. Dist. LEXIS 103944 (S.D. N.Y. Aug. 7, 2015). The parties’ settlement now accepts the court’s decision, reflecting a fundamental change in FDA’s previous policy of effectively prohibiting any off-label marketing by prescription drug and medical device companies, regardless of whether the proposed speech was objectively truthful.

The settlement comes after a series of high-profile losses for FDA and the DOJ in the government’s attempt to prohibit and criminalize truthful off-label marketing. Continue Reading Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on various regulated products.  There was no shortage of significant Agency actions in 2015 related to therapeutic and diagnostic products, which include traditional chemical drugs, biological products, medical devices and diagnostic tests, and even stem cell therapies and human tissue products.  Also noteworthy is that FDA is reporting that as of December 14th it had granted approval to 42 groundbreaking new drugs (called “new molecular entities” or NMEs) and therapeutic biological products during the calendar year.  The figure so far for this year beats 2014’s final count of 41 approved NMEs and far exceeds the prior year’s total of 27 NMEs.  This post will highlight some of FDA’s significant actions this year and provide our thoughts about what next year may bring for FDA-regulated entities.
Continue Reading FDA Legal and Regulatory – 2015 Year In Review

Written by: Rachel M. Irving

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will plead guilty to criminal misbranding charges relating to the off-label promotion of its drug Risperdal. This settlement closes the last of the DOJ’s cases investigating off-label promotion of antipsychotic drugs by major pharmaceutical companies — investigations that resulted in settlements over Astrazeneca’s Seroquel, Bristol Myers Squibb’s Abilify, Eli Lilly’s Zyprexa, and Pfizer’s Geodon, as well as a settlement with long-term care pharmacy Omnicare.

Off-Label Promotion and Kickback Allegations

J&J’s settlements resolve allegations in two separate false claims act cases alleging that J&J and Jannsen promoted the antipsychotics Risperdal and Invega for off-label uses, and another false claims act case alleging that J&J and its subsidiary Scios promoted the heart failure drug Natrecor for off-label use. The settlements also address allegations that J&J paid physicians and nursing home pharmacies kickbacks to prescribe and supply these drugs to patients. In its Civil Settlement Agreement, J&J denies the government’s allegations and does not admit any wrongdoing, except for the limited admissions made in the plea agreement for the Pennsylvania criminal charges. To settle those charges, Jannsen admitted that it promoted Risperdal to providers for use in elderly, non-schizophrenic dementia patients to treat certain psychotic symptoms and related behavioral disturbances, even though Risperdal was approved only to treat schizophrenia at the time.

Continue Reading J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges