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FDA Plans Meeting to Discuss Regulations on Off-Label Drug Use

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A number of women have blamed the anti-nausea drug Zofran (ondansetron) for causing their children’s birth defects. Had they known that the drug could increase risk of such defects, many say, they never would have taken it.

Unfortunately, Zofran manufacturers GlaxoSmithKline (GSK) conducted a large advertising campaign to convince both doctors and pregnant women that Zofran was safe and effective to use during pregnancy. Yet the Food and Drug Administration (FDA) had not approved the drug for use in pregnant women. When the agency cleared the drug for market in 1991, they did so for the treatment of nausea and vomiting only in patients undergoing chemotherapy or who were emerging from surgery.

Doctors are allowed to prescribe medications for any purpose they think is appropriate for any particular patient. Drug companies, however, are not allowed to promote so-called “off-label” uses in their advertisements and marketing materials. GSK was fined $3 billion in 2012 for doing just that with Zofran and other drugs.

Amidst complaints like these, the FDA is taking a second look at regulations concerning off-label drug marketing.

Pharmaceutical Companies Want the FDA to Back Off

According to Scientific American and news media outlets, the FDA has scheduled a public meeting to discuss off-label drug use with the public. The meeting seems to be in response to a new bill going through congress called “21 Century Cures,” which includes language designed to force the FDA to relax its restrictions on off-label drug use and advertisement.

A group of drug companies known as the “Medical Information Working Group”—including GSK, Johnson & Johnson, Sanofi, Pfizer, Eli Lilly and Company, Novartis AG, and others—recently filed a petition calling for an easing of FDA restrictions.

On May 7, 2015, Amarin Pharma also filed a lawsuit against the FDA, stating that the administration prohibits them “from making completely truthful and non-misleading statements about its product to sophisticated healthcare professionals.” Doctors are on the front lines, pharmaceutical companies complain, trying to help at-risk patients every day, and need information about drugs that may be of use.

“The U.S. Food & Drug Administration’s current regime for regulating the flow of ‘off-label’ information to doctors about prescription drugs, however,” the company states in its complaint “severely restricts medical professionals’ access to information from the source most knowledgeable about the drugs: the drug manufacturers….”

Easing Restrictions Could Put Lives at Risk

Many doctors, however, argue that pharmaceutical companies are not the best source of information when it comes to what their products can do, and do safely. Women who took Zofran for its off-label use of preventing morning sickness and then gave birth to children with birth defects may also argue that giving companies even more freedom when it comes to touting a drug’s potential benefits could be dangerous.

“People do not realize that the consequences of this new ideological approach to the First Amendment will be measured in lives,” Dr. Joshua Sharfstein, former principal deputy commissioner at the FDA, told Scientific American.