FDA to Decide Whether Drug Companies Have a Constitutional Right to Make Certain Claims About Their Products

This summer, the U.S. Food and Drug Administration (FDA) will hold a public meeting to discuss whether restricting drug companies from making certain claims about their products infringes on the firms’ liberties.

HealthNewsReview.org reports that since the 1960s, the FDA has required drug manufacturers to prove the efficacy of their products. The requirement was sparked by thalidomide. The drug was originally marketed as a calming medicine in Germany in 1957 as a “completely harmless, mildly soporific medicine,” according to Thalidomide.org. In reality, thalidomide caused serious birth defects, and by the beginning of the 1960s, more than 12,000 children in 48 countries were born with injuries caused by the medication.

At that time, Congress gave the FDA new authority to ensure that useless or minimally effective products, or downright dangerous drugs, could not be introduced to the market. The agency then assessed thousands of drugs on the market remove those that were ineffective, dangerous or both. “The summer of 2015 could mark the beginning of a step back to the pre-1960s era for prescription drugs,” according to HealthNewsReview.org.

The FDA is considering allowing drug companies to bypass the review process for the totality of the available data, including secret proprietary files. The agency is also debating whether to permit companies to present clinicians with “cherry-picked” studies that frame drugs in a positive light on their own, but could be methodically inadequate, or fail to fairly represent both the drugs’ risks and benefits, HealthNewsReview.org reports.

Under the agency’s potential new rules, companies would be allowed to present unreliable “clinical experience” measures such as “observational studies, registries, and therapeutic use” as well as guidelines to assess efficacy to promote the safety and efficacy of their products, according to HealthNewsReview.org.

Scientific American wrote that the FDA meeting comes “as a bill known as 21st Century Cures, designed to speed new drugs to market, is moving through Congress. Language in the bill is adding pressure on the agency to relax its guidelines.”

One example given by the Wall Street Journal’s (WSJ) Pharmalot block is the case of a small drug maker known as Amarin. The company filed a lawsuit against the FDA arguing that it has the right to distribute information about unapproved uses of a medicine under the First Amendment. Amarin wants the freedom to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa prescription fish-oil supplement. The FDA approved the pill to treat people with very high levels of triglycerides; now Amarin wants to provide doctors with data about the effectiveness of Vascepa to treat people with slightly lower triglyceride levels. The FDA last month rejected Amarin’s request to market the pill to that patient population, as well as the company’s plan to add the data to the Vascepa product labeling. Amarin is asking a federal court in New York to “declare [that] it may engage in its proposed speech about Vascepa,” according to Pharmalot, which viewed lawsuit documents.

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