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International Reference Pricing for Medicare Drugs: New Lease on Life or Least Likely to Succeed?

On Sunday, September 13, 2020, President Donald Trump issued a long-anticipated Executive Order on international reference drug pricing (the “EO”), signaling that rulemaking on the prices that the Medicare program pays for drugs may be underway again. The EO introduces some new concepts for international reference drug pricing, including, significantly, application to Medicare Part D as well as Part B, and an even lower international reference price. However, like its predecessor pronouncements, the EO provides no specifics for implementation, leaving it unlikely that any changes to the Medicare program contemplated by the EO will go into effect, if ever, before the 2020 election, by the end of the year, or soon thereafter.

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COVID-19 Disruptions of International Clinical Trials: Comparing Guidances Issued by FDA, EMA, MHRA and PMDA

Practices: Health Care

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The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Recognizing this impact, national authorities have issued guidance for sponsors, investigators and institutional review boards (IRBs)/research ethics committees (RECs) regarding the conduct of clinical trials. The chart below summarizes guidance from the U.S. Food and Drug Administration (“FDA”) (updated March 27, 2020), the European Medicines Agency (“EMA”) (dated March 27, 2020), the United Kingdom Medicines and Healthcare Products Regulatory Agency (“MHRA”) (updated March 24, 2020), and Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) (dated March 27, 2020).

View the PDF to read the guidance.

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