“Off-Label” Drug Marketing to be Reviewed During FDA Meeting

Amid complaints by pharmaceutical companies that bans on off-label drug marketing violate First Amendment rights to free speech, the FDA indicates that it will hold a public meeting to discuss the federal regulations that prohibit drug manufacturers from promoting medications for uses that have not been approved as safe and effective.

Last month, FDA chief counsel Elizabeth Dickinson announced that the FDA will hold a public meeting sometime this summer on off-label restrictions, according to a Reuters article published on May 4. No official announcement of the meeting or a date has yet been released.

The meeting’s announcement came just days before Amarin Pharma filed a First Amendment Lawsuit against the FDA on May 7. The complaint (PDF) was filed in the U.S. District Court for the Southern District of New York, alleging that the FDA prevents the company from making “completely truthful and non-misleading statements” about its products to doctors, four of whom are participants in the lawsuit.

Off-label promotions occur when a drug company communicates to the medical community or the public that it’s drugs can be used for in ways that have not been approved by the FDA. While doctors can prescribe drugs for any use they see fit, it is illegal for pharmaceutical companies to promote off-label uses until they have conducted necessary studies and research to establish that the indication is safe and effective.

Consumer advocates support off-label drug marketing bans, indicating that pharmaceutical companies should not be allowed to place their desire for profits before consumers safety by promoting unapproved uses, until they have conducted thorough studies and FDA reviewers approve the additional use.

According to some of the lawsuits filed by pharmaceutical companies, bans on off-label marketing prevent doctors from getting truthful and non-misleading information about drugs for off-label uses that could help them better decide what drugs to prescribe to their patients. Specifically, Amarin Pharma says the FDA’s regulations prevent the company of promoting the findings of a study that indicates that the drug Vascepa, could be useful in treating patients with high triglyceride levels.

Currently the FDA has only approved the drug for use in patients with hypertriglyceridemia, which refers to consistently high triglyceride levels of 500 mg/dL or above. However, the company wants to be able to promote the drug to doctors for use in patients with triglyceride levels of 200-499 mg/dL based on the findings of a study called ANCHOR. The company points out that doctors are legally already prescribing the drug for that use, but the company is not legally allowed to promote the ANCHOR findings in support of such use.

While pharmaceutical companies say it steps on their First Amendment rights when their promotions pass on truthful information. there are a number of recent cases in which drugs were promoted off-label for uses that were later linked to severe, and sometimes fatal, side effects.

Off-Label Drug Risks

In November 2013, Johnson & Johnson agreed to pay $2.2 billion to the federal government to settle its Risperdal illegal marketing claims. Investigators say that the illegal marketing led to the unnecessary and risky use of drugs like Risperdal, which is sometimes used in nursing homes as a form of chemical restraint, potentially putting dementia patients’ lives at risk.

The DOJ began investigating Johnson & Johnson’s marketing of Risperdal in 2004, looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes.

Although federal drug regualtors and other safety officials have been working to reduce the use of antipsychotics in nursing home patients, indicating that the drugs carry little benefit for dementia patients and may increase the risk of death, widespread overuse of the medications continues to be a problem following years of illegal marketing.

Off-label use of the anti-nausea drug Zofran has also been a concern in recent years, after GlaxoSmithKline was charged with off-label drug promotion several years ago. Promoting Zofran for pregnancy-related morning sickness was among the claims that led to a $3 billion settlement with the federal government, as the drug maker never conducted any studies to establish that Zofran use while pregnant was safe for unborn children.

The company now faces a growing number of Zofran lawsuits from women who gave birth to children who suffered congenital heart problems, cleft palate, cleft lip and other birth defects. Critics point out that, for those children, the penalties against GlaxoSmithKline came too late and many doctors are still unaware of Zofran pregnancy risks.

In November 2011, a study published in the medical journal Birth Defects Research Part A: Clinical and Molecular Teratology concluded that women may be 2.37 times more likely to give birth to a child with a cleft palate following Zofran use. This may leave children with a severe facial deformity, which can occur when development of the fetus is impacted during the first trimester.

Additional studies have also identified potential Zofran heart defect risks. An August 2013 study that reviewed data on more than 900,000 pregnancies in the Danish Medical Birth Registry found that children may be 2 to 4 times more likely to suffer a septal defect, involving holes in the heart, following Zofran exposure.

More recently, a study published by the medical journal Reproductive Toxicology in October 2014 found that there is a statistically significant increased risk for certain heart defects with Zofran use early in pregnancy.

Lawsuits filed on behalf of children born with birth defects claim that GlaxoSmithKline should have undertaken a comprehensive study on the potential pregnancy side effects of Zofran and warned about the chance that unborn children may develop birth defects.