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A service for medical industry professionals · Wednesday, November 14, 2018 · 468,255,456 Articles · 3+ Million Readers

HHS Secretary Azar Directs FDA to Establish Working Group on Drug Importation to Address Price Spikes

As part of the Trump administration’s efforts to lower drug prices and put American patients first, Health and Human Services Secretary Alex Azar requested today that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.

“We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients,” said Secretary Azar. “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent.

“Safe, select avenues for importation could be one of the answers to these challenges. When HHS released the President’s Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.

“Importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue, and appreciate the voluminous work FDA has done to increase competition in America’s drug markets.”

Further Background

Why is the Trump administration launching this working group?

President Trump and Secretary Azar have consistently maintained that HHS is willing to explore all ways to tackle the soaring price of drugs while protecting incentives for innovation and maintaining standards of patient safety and access. The working group will examine importation of drugs that have seen significant price increases or significant access challenges for patients.

How does this compare with other importation proposals?

This working group will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer. This stands in contrast to proposals to import a broader range of drugs, which raise additional questions about how to protect American patients.

The working group will consider drugs unprotected by patents or exclusivities, which will allow other manufacturers to introduce new competition.

Because the drugs being considered for importation are off-patent and have no exclusivity remaining, the proposals contemplated by the working group would not dilute intellectual property rights or affect incentives for innovation. Rather, they would provide a new avenue for competition to drive down prices for American patients.

Is safe importation possible?

The Food and Drug Administration’s gold standard for safety and effectiveness is unimpeachable, and will guide the working group’s efforts. Importation will be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness.

Putting American patients first, as President Trump aims to do, means not just delivering lower prices, but also ensuring that all Americans can expect that the drugs they purchase are safe and effective.

Haven’t administrations traditionally rejected proposals like this?

President Trump has called for action on drug prices, and HHS under Secretary Azar has answered with aggressive legislative proposals and sweeping potential regulatory reforms of drug pricing. The Secretary remains committed to receiving input from stakeholders and will continue to implement the President’s American Patients First Blueprint. The FDA working group is only one portion of a larger reform package being coordinated by HHS.

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