FDA to Develop Importation Policy for Sole-Source Drugs

Regulatory NewsRegulatory News | 19 July 2018 |  By 

At the direction of Department Health and Human Services (HHS) Secretary Alex Azar, the US Food and Drug Administration (FDA) on Thursday announced it will work to develop a policy to facilitate the importation of certain sole-source drugs in response to dramatic price hikes and supply disruptions.

The policy is an attempt to head off the tactic employed by Martin Shkreli and Turing Pharmaceuticals in 2015 when it acquired the off-patent drug Daraprim (pyrimethamine), then massively raised the price of the drug.

"For certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer; conditions may develop that create significant barriers to, and ultimately threaten, patient access," said FDA Commissioner Scott Gottlieb.

Those conditions, Gottlieb said, include supply chain issues or "significant price increases," which have a similar impact on patients as drug shortages.

So far the announcement has received pushback from industry, with the Pharmaceutical Research and Manufacturers of America (PhRMA) recommending the agency look to other approaches to promote competition, and the Biotechnology Innovation Organization (BIO) suggesting that importing foreign versions of drugs would undermine patient safety.

Going forward, Gottlieb said that FDA will assemble a work group to develop specific policies around importing foreign versions of sole-source, off-patent/off-exclusivity drugs.

Some of the issues the work group will need to address are the statutory and regulatory considerations for implementing such a policy, how FDA will define disruptions under the policy and how the agency will ensure that the imported drugs are safe and effective and have adequate labeling.

According to Gottlieb, the work group will also make sure that the policy does not discourage manufacturers from seeking FDA approval of additional versions of sole-source drugs.

Gottlieb also emphasized that any importation of foreign versions of drugs would be temporary "until adequate competition enters these categories."

"Our ultimate goal is to seek multiple FDA-approved and marketed versions of each medically important drug for which there are no blocking patents or other exclusivities," he said.

Senate HELP Committee Chairman Lamar Alexander (R-TN) said he's glad to see HHS and FDA looking into importation as a means of increasing competition as long as the safety and effectiveness for those products is ensured.

"The Food and Drug Administration already approves the manufacture of prescription drugs in facilities overseas and it approves safe supply chains for those prescription drugs, so it makes sense to explore whether the FDA can do that in specific instances that increase competition and lower prices," he said.



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