FDA to Consider Policy Change Allowing Certain Prescription Drug Imports

This story has been updated.

For the first time, HHS and the FDA said Thursday the idea of allowing the importation of prescription drugs from other countries will be considered, if the drug met certain conditions.

FDA Commissioner Scott Gottlieb, MD, said a work group will develop policy options aimed at certain sole-source medications. HHS Secretary Alex Azar cited “price hikes and supply disruptions that are harming American patients” for the reasons the government is considering this option.

Specifically, the United States is looking at drugs that do not have blocking patents or exclusivities.

Allowing the importation of drugs was not part of President Donald Trump’s plan announced earlier this year to lower drug prices, but in his statement, Azar said when HHS released the plan that “we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.”

Gottlieb said allowing the short-term importation of drugs could spur competition in the domestic market. Thursday’s news comes a day after Gottlieb announced the FDA’s Biosimilar Action Plan.

In 2016, a bipartisan Senate plan advocated for a highly targeted drug import strategy as 1 measure that could help stop huge price hikes. Senators Susan Collins, R-Maine, and Claire McCaskill, D-Missouri, as chair and ranking member of the Senate’s Special Committee on Aging, issued findings from 4 case studies involving Turing Pharmaceuticals’ Daraprim, Retrophin’s Thiola, Rodelis Therapeutics’ Seromycin, and 4 drugs from Valeant Pharmaceuticals.

Azar cited the case of Daraprim, a drug approved in 1953, in his statement today. Turing Pharmaceuticals became infamous for price gouging when the per-tablet cost of Daraprim soared from $13.50 to $750 in a single day.

A few of the things the FDA said the work group will consider when creating a policy are:

• Relevant statutory and regulatory requirements;
• How the FDA will define an access dislocation in these circumstances;
• How the FDA and HHS will evaluate the public health need;
• How the agency will assess the safety, effectiveness, and labeling of a foreign-approved drug.

Pharmaceutical Research and Manufacturers of America, the industry trade group representing pharmaceutical companies, has long been opposed to any importation of drugs. In previous roles before joining the Trump administration, Azar and Gottlieb were as well.

Separately Thursday, Azar praised Merck’s announcement that it was, like Pfizer and Novartis, going to roll back some price increases. The company said it was cutting the price of its hepatitis C drug Zepatier by 60% and several other medicines, which it did not name, by 10%.

Also, Merck said it commits “to not increase the average net price across our portfolio of products by more than inflation annually.”

Merck said the products chosen for price reductions “were based on a range of factors including the gap between list price and actual discounted (net) prices paid in the market, the contractual obligations under existing arrangements with payers, and the opportunity to broaden access to treatment.”

However, The New York Times reported Friday that the company chose not to cut the prices of any blockbusters like the cancer treatment Keytruda or the diabetes drug Januvia, and the sales of Zepatier have dipped so low that after paying rebates to insurers, the company recorded no sales in the first quarter of the year.