Drugs

U.S. Should Protect Drug Innovation: Associations

Associations representing the innovative and generic drug industries say the U.S. should be using its trade policy to defend and protect American inventions. The Association for Accessible Medicines (AAM) and Pharmaceutical Research and Manufacturers of America (PhRMA) made the plea in comments to the United States Trade Representative on the 2022 Special 301 review on matters related to trade and the protection of intellectual property rights.

AAM says that while the Section 301 review is not a trade negotiation covered by the 2015 Trade Priorities and Accountability Act, “it still should reflect the balance between innovation and access that has been affirmed by Congress” in the act. “Generic, biosimilar, and brand-name drug companies require access to foreign markets to continue to grow and generate jobs here in the U.S.,” AAM says. “It is important to ensure that any new ex-U.S. intellectual property rights (IPR) provisions do not create more difficult barriers for U.S. generic and biosimilar products to enter foreign markets. Following the guidance set out in TPA to balance innovation with access will encourage balanced IPR regimes that give companies certainty about the regulatory framework in which they operate, maximizing the impact of U.S. exports and domestic job creation.”

In its comment, PhRMA says “urgent action is required to address serious market access and intellectual property matters” in overseas markets named in the letter. “Biopharmaceutical innovators in the United States face a wide array of damaging government pricing policies abroad that undervalue American innovation, threaten billions of dollars in lost sales, and put American competitiveness, jobs, and exports at risk.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome