Drugs

Tillis Wants FDA, USPTO Patent Data Study

Sen. Thom Tillis (R-NC) says some advocacy groups are using potentially inaccurate and false narratives to allege that drug companies misuse patent laws to delay generic competition and drive up prices. He has asked FDA and the U.S. Patent and Trademark Office (USPTO) to conduct an independent study on the sources and data that are being used by those advocating for patent-based solutions to drug pricing, according to a report by three Jones Day attorneys.

The attorneys say Tillis particularly cited the Initiative for Medicines, Access & Knowledge (I-MAK) and its claims that drug makers use patent laws to extend their monopolies in ways not contemplated by U.S. patent law. Tillis reportedly has written to I-MAK asking for an explanation of its methodology and why the numbers are so dramatically different from public sources to further support an independent review of the issue.

The post lists these three takeaways:

FDA and the USPTO continue to be criticized for the role that the drug patent system plays in drug pricing in the U.S.;
the methodology underlying analysis by drug critics such as I-MAK is opaque and discrepancies between their reports and other sources of information call into question reliance on these analyses when considering new patent or regulatory policies; and
Tillis’ letter highlights important concerns and the need to ensure that any policy changes are based on reliable and accurate data.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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