FDA relaxes guidelines for abortion-inducing drug, flames abortion controversy

The FDA announced a labeling change for the drug Mifeprex®, which, when used together with another drug called misoprostol, will terminate a pregnancy in the early stages. The labeling change will relax certain guidelines in prescribing practices and expand the time in which women can take this drug in order to induce an abortion. This change comes at a controversial time as the Supreme Court just heard oral arguments, and oddly asked parties for additional briefing, in a challenge to the contraception mandate under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). At the same time, anti-abortion candidates in the race to the White House have recently fueled the fire with inflammatory remarks while some pro-life proponents are framing the FDA’s change as a political move.

Labeling changes

While the FDA first approved Mifeprex in 2000, the latest announcement outlines a new approved regimen which was found to be safe and effective after a supplement application was submitted by the manufacturer. The FDA stated that the drug may be appropriately used to end a pregnancy through 70 days of gestation and through the following procedure:

  • The ingestion of 200g of Mifeprex on day one;
  • The ingestion of 800mcg of misoprostol 24 to 48 hours after taking the Mifeprex; and
  • A follow-up with a health care provider seven to 14 days after taking the Mifeprex.

The FDA also outlined an appropriate risk evaluation and mitigation strategy (REMS) for Mifeprex, as follows: (1) that it must be ordered, prescribed, and dispensed under the supervision of a health care provider with certain qualifications; (2) that those health care providers must complete a Prescriber Agreement Form before prescribing; (3) that it only may be dispensed in clinics, medical offices, and hospitals; and (4) the provider must obtain a Patient Agreement Form before dispensing it.

Effect

Other than extending the time in which this medication can be prescribed from seven weeks to 10 weeks, the new labeling reflects a change in dosage and procedure that, according to some sources, was adopted by physicians that prescribed Mifeprex off-label long ago. “The change brings the direction for taking the drug . . . in line with what has become standard medical practice in most states: reducing the dosage to 200 milligrams from 600 milligrams, decreasing the number of visits a woman must make to the doctor to two from three, and extending the period when she can take the pill to 10 weeks of pregnancy from seven weeks,” according to the New York Times. There is also evidence that fewer side effects accompany the lower dosage. The same article notes that while the new labeling might be applicable to all states at the moment, at least one state is already working to pass a law that would hold provider’s to the stricter standards imposed in the past.

Context

This FDA approval came at an interesting time for the abortion and contraceptive coverage controversy as, the day before this announcement, the Supreme Court issued an order asking for supplemental briefing in a case on which it had heard oral arguments the previous week and which challenged the contraception coverage mandate of the ACA. Some experts see this as the eight-Justice Court potentially looking for an avenue to strike a compromise on an issue and avoid a 4-4 vote, which would effectively result in the continuation of a circuit split and different laws applying in different jurisdictions on this issue. In this context, pro-life proponents argued that the FDA announcement is a politically fueled move to satisfy the “abortion industry” and pro-choice groups. Others defended it as unrelated to election year politics and as simply part of the FDA’s regulatory responsibility in the face of a supplement drug application.

21st Century Oncology faces class actions in wake of data breach

Following a data breach of the nationwide cancer center, 21st Century Oncology, patients filed multiple class action lawsuits against the provider alleging that 21st Century failed to establish adequate cybersecurity measures in violation of federal and state law. Although the breach impacted an alleged 2.2 million patient records, the provider notified patients that it does not believe medical records were accessed or information was misused as a result of the breach. One of the class action complaints condemns the provider’s lack of control over protected health information (PHI), saying, “the last thing patients dealing with potentially deadly illnesses need is further harm and stress caused by the insecurity of their most private data and how it may be used by thieves.”

Lawsuits

In a complaint filed on March 23, 2016, several patients alleged that the provider was not aware that it had been infiltrated until notified of the breach by the FBI. Although investigators informed the provider of the breach on November 12, 2016, 21st Century announced it was instructed not to inform patients until this month. The lawsuits allege that data stolen by thieves includes patients’ names, Social Security numbers, physicians’ names, medical diagnoses, treatment information, and insurance information. One lawsuit asserted that the content of the 2.2 million current and former patients may have been copied and transferred as a result of the breach. The complaints allege that the provider violated the Health Information Portability and Accountability Act (HIPAA) (P.L. 104-191) and industry data protocols, was negligent in its safeguarding of PHI, was in breach of the implied covenant of good faith and fair dealing, and, in some cases, violated state consumer protection laws.

Prior breach

One lawsuit alleges that 21st Century is not a stranger to data breaches. Specifically, the complaint alleged that between October 11, 2011 and August 8, 2012, a 21st Century employee provided PHI to a third party who used the information—names, Social Security numbers, and dates of birth—to file fraudulent tax refunds. The complaint alleged that 21st Century also failed to detect the earlier breach.

21st Century

According to 21st Century’s announcement on the more recent breach, the provider is notifying affected patients and offering them free one-year credit protection services. Some of the lawsuits acknowledge the provider’s offer and call it inadequate, suggesting that the threat and harm resulting from the breach is more serious than the compensation reflects and will last longer than a year. The lawsuits follow a settlement earlier this month, where 21st Century agreed to pay $34.7 million to settle claims that it billed Medicare and Tricare for medically unnecessary radiation tests between 2009 and 2015.

First suit filed against Dole in international Listeria outbreak

The adult daughter of an ailing consumer has filed a lawsuit against Dole Fresh Vegetables, Inc., a Division of Dole Food Company, Inc. (Dole), related to a deadly Listeria outbreak in the United States and Canada. In the complaint, the daughter seeks unspecified damages for her mother, who allegedly became ill in January 2016 and eventually fell into a coma after eating part of a packaged salad from Dole’s Springfield, Ohio, production facility.

According to the complaint, filed in the U.S. District Court for the Southern District of Ohio, since July 5, 2015, at least 18 people in the United States and 11 in Canada have been infected with Listeria as a result of their consumption of Listeria-contaminated leafy green products produced by Dole at its processing facility in Springfield, Ohio. Listeria (listeriosis) is a serious infection usually caused by eating food contaminated with the bacterium Listeria monocytogenes. The complaint further alleges that:

  • Whole genome sequencing has been performed on Listeria specimens collected from all ill people and has shown that they are highly related genetically.
  • Listeria specimens were collected from ill people in the U.S. between July 5, 2015 and January 31, 2016.
  • All 18 ill people from the U.S. were hospitalized, including one person from Michigan who died as a result of listeriosis.
  • The 11 individuals from Canada became sick between May 2015 and early January 2016.
  • Some of the ill Canadians have reported eating packaged salads produced at the Dole facility in Ohio.
  • All ill Canadians have been hospitalized, with three people dying.

On January 27, 2016, Dole announced that it was temporarily suspending operations at its Springfield, Ohio facility and voluntarily recalling all salad mixes produced at that facility. At this time, there is no evidence to suggest that any products produced at other Dole processing facilities in the U.S. are linked to illness.

Since September 2015, the Centers for Disease Control and Prevention (CDC) has collaborated with public health officials in several states, the U.S. FDA, and the Public Health Agency of Canada to investigate the outbreak.

On January 28, 2016, the FDA completed its analysis and confirmed the presence of Listeria monocytogenes in a packaged salad produced at the Springfield, Ohio, facility. The FDA warned that consumers should not eat, and restaurants and retailers should not serve or sell, packaged salads produced at the facility.

Amarin settlement may open the door to more expansive off-label use

Dublin, Ireland based Amarin Pharma, Inc., (Amarin) and the FDA have entered into a proposed settlement in the First Amendment litigation involving Amarin’s off-label promotion of its approved cardiovascular drug Vascepa® (icosapent ethyl). Under the terms of the proposed settlement, which must be approved by the U.S. District Court for the Southern District of New York, the FDA and the U.S. government have agreed to be bound by an August 7, 2015, judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and that certain statements and disclosures that Amarin proposed to make to health care professionals are truthful and non-misleading.

The specific statements Amarin sought to make about Vascepa were derived largely from an FDA-approved study of Vascepa’s off-label use and FDA writings on that subject. Amarin contended, and the FDA largely conceded, that the statements were truthful and non-misleading. The FDA, however, recognizing that Amarin’s purpose in making these statements would be to promote an unapproved use of Vascepa, threatened to bring misbranding charges against Amarin if it did so. Amarin claimed that the FDA’s threat of a misbranding action chilled it from engaging in constitutionally protected truthful speech.

Amarin’s complaint

On May 7, 2015, Amarin sought preliminary relief to ensure its ability to engage in truthful and non-misleading promotion of Vascepa, free from the threat of a misbranding action. Amarin asserted in its complaint that the FDA’s current regulatory policy restricted the transmission of truthful information from manufacturer to physician about the off-label use of pharmaceuticals in a manner that violates the First Amendment of the U.S. Constitution (see Off-label speech restrictions should go overboard to fish-oil manufacturers lawsuit, Health Law Daily, May 11, 2015).

The issue of whether the FDA has authority to regulate statements about the unapproved uses of medicines has been around for some time. For example, in 2012, the Second Circuit overturned the criminal conviction of a sales representative who had promoted the off-label use of Xyrem®, a central nervous system depressant. The court held that the criminalization of the sales representative’s truthful and non-misleading statements was a violation of the sales representative’s speech rights (see Conviction for promotion of off-label use violated First Amendment, Health Law Daily, December 4, 2012).

District court ruling

On August 7, 2015, the Southern District of New York issued its ruling in favor of Amarin (see Hold your horses, FDA: no misbranding action for truthful off-label promotion, Health Law Daily, August 10, 2015). The court concluded that to avoid infringing on the First Amendment, the federal Food, Drug and Cosmetic Act must be construed by the FDA as not prohibiting or criminalizing the truthful off-label promotion of FDA-approved prescription drugs, where the off-label use itself is lawful, which the FDA had conceded.

The roadmap to Amarin’s off-label victory at the district court can be found via decisions in the last half decade that would eventually reach the U.S. Supreme Court in a matter concerning commercial speech. In Sorrell v. IMS Health, the high court concluded that commercial speech, including speech related to the marketing of drugs, is protected under the First Amendment as long it is not false or misleading (see Supreme Court favors pharmaceuticals in twin decisions, Health Law Daily, July 7, 2011).

Additional settlement terms

Additional elements of the proposed Amarin settlement include:

  • The FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims.
  • The parties have agreed to a dispute resolution provision designed to avoid future litigation on matters arising under the settlement order.
  • The court would retain jurisdiction over the matter to ensure compliance with and resolve any future dispute arising from the settlement order.

Clinical studies will continue

Amarin announced that it remains strongly committed to completing the ongoing REDUCE-IT cardiovascular outcomes study. This study is designed to test whether Vascepa, when added to statin therapy, will significantly reduce cardiovascular risk compared to statins alone in high-risk patients with elevated triglyceride levels.

Leveraging the Amarin victory

The pharmaceutical industry has taken notice of Amarin’s First Amendment victory and may be in the process of leveraging the decision to allow for more expansive drug indications via truthful off-label promotion. For example, on September 8, 2015, Pacira Pharmaceuticals, Inc. filed a lawsuit in the same federal court, seeking to prevent the FDA from bringing an enforcement action against Pacira for what it claims is truthful and non-misleading speech concerning its sole product, Exparel® (see Commercial speech waters turn murky, Health Law Daily, October 20, 2015).