Last week, President Biden signed a comprehensive pro-competition Executive Order with various requirements affecting medical product supply chains, such as the ability to import prescription drugs from Canada and banning “pay for delay” between pharmaceutical manufacturers. Please see details for this and other supply chain developments below:
- On July 8, Pfizer and BioNTech announced that the ongoing trial of the Pfizer/BioNTech COVID-19 vaccine booster dose had generated encouraging data. The companies plan to submit the data to the FDA and other regulatory authorities in the coming weeks. It was also reported that Pfizer will meet with federal health officials on July 12 to discuss the need for the booster dose. See Reuters’ reporting here.
- On July 8, the White House COVID-19 Response Team announced that nearly 160 million Americans had been fully vaccinated and 182 million Americans had received at least one shot.
- On July 9, President Biden signed the Executive Order on Promoting Competition in the American Economy. This sweeping pro-competition Executive Order includes the following points that will likely affect medical product supply chains:
- Requiring HHS to submit a plan within 45 days to reduce prescription drug prices and enhance domestic pharmaceutical supply chains.
- Requiring the FDA to cooperate with states and tribes that intend to import prescription drugs from Canada under Section 804 of the Federal Food, Drug, and Cosmetic Act.
- Encouraging the FTC to ban by rule “pay for delay” and similar agreements between pharmaceutical manufacturers.
- Requiring HHS to issue proposed rules within 120 days to allow hearing aids to be sold over the counter.
- Directing relevant agencies to confront anticompetitive activity in ocean-shipping and railroad industries.
- On July 9, the FDA released a report to summarize the impact of additive manufacturing/3D printing on the overall COVID-19 response. The report focuses on assessing the producers of additively manufactured PPE products and the recipient health care communities from February 15 to July 15, 2020.
- On July 10, the G20 Finance Ministers and Central Bank Governors endorsed the key components of the global tax reform on the reallocation of profits of multinational enterprises and an effective global minimum tax.