Lawmakers’ Move To Allow off-Label Marketing Opposed By Public Citizen

A lawmaker’s call to loosen the restrictions on drug marketing, which would effectively allow pharmaceutical companies to promote the drugs for uses that they never established were safe or effective, is getting backlash from consumer watch groups. 

On May 26, Representatives Fred Upton, chairman of the House Committee on Energy and Commerce, and Joseph Pitts, who chairs the subcommittee on health, sent a letter (PDF) to Sylvia Burwell, secretary of the U.S. Department of Health and Human Services, urging that the FDA allow drug manufacturers to give doctors and others information on the use of drugs for indications that were never approved by the regulatory agency. The letter also included a draft bill to alter the off-label marketing rules.

The letter sparked a response from the prominent consumer advocacy group Public Citizen, which indicates that the move would weaken patient protections that are a key part of the FDA’s duties.

At issue is the FDA’s policy against off-label marketing, which makes it illegal for drug companies to promote their drugs for uses not approved by the agency following an evaluation of data that establishes the medications are safe and effective for that indication. While doctors can prescribe a drug that is on the market for any reason they see fit, including such off-label uses, manufacturers are currently prohibited from promoting the medication for indications other than those approved by the FDA.

Upton’s letter accuses the policy of being unconstitutional and points to a number of recent court rulings, which he indicates protects drug manufacturers under the auspices of freedom of speech. The proposed change would allow the companies to include data on studies and research to doctors and the public involving medication uses that have not yet been proven safe or effective.

Critics call the maneuver a backdoor way to allow drug companies to increase profits and promote their drugs for potentially unsafe uses, which may turn consumers into unwilling test subjects.

In the press release, Public Citizen said the letter from Upton and Pitts “shows a lack of appreciation for the role of the FDA in protecting patient health and a naive view of industry marketing practices.”

“The threat to patient health posed by the draft bill attached to their letter is tremendous,” Public Citizen warned. “FDA approval of a product for one use….tells us nothing about whether it is safe and effective for another use,” Public Citizen states. “Yet this bill would allow drug and medical device manufacturers to advertise and promote their products — both to doctors and directly to consumers — for uses never approved by the FDA.”

The bill would only require that the companies back up such claims with scientific evidence, but Public Citizen points out that there have been repeated examples of the drug industry skewing the results of studies involving its own drugs in an effort to increase sales and profits.

A study published last year in JAMA Internal Medicine found that off-label use of drugs places patients at a 44% increased risk of suffering an adverse drug event.

Drug Companies Often Penalized for Violating Drug Marketing Laws

In recent years, the FDA has cracked down on a number of major drug companies for off-label promotion violations.

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 regulators 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.