Drugs

Drug Companies Nervous About FDA Reg Rollback

Drug company executives contacted by Reuters expressed anxiety about President Trump’s vow to roll back federal regulations at least 75%. They say they fear that a less robust FDA would make it harder to secure insurance coverage for pricey new medicines. The Biotechnology Industry Group told Reuters that in discussions with administration advisors, the trade group urged the administration not to name a new FDA commissioner who would act rashly to speed the agency’s approval of new medicines.

And executives at more than a dozen pharmaceutical and biotechnology companies told the news service that the agency is already adopting new drug development models and warned that a looser review process would put patients at risk.

“People often argue that FDA is too restrictive,” said Merck research and development head Roger Perlmutter. “We have the sense that the balance is pretty right. You have to have a well-characterized risk/benefit profile.”

While most industries welcome less oversight, Reuters explains, drugmakers say a robust review process is critical in convincing doctors and insurers that a pricey new medicine has value. “It’s great that the administration is seeking deregulation, to make sure the private sector can be more competitive,” said Alnylam Pharmaceuticals CEO John Maraganore. “But payers are looking for evidence of value.” He said that FDA should speed approval of generic versions of drugs that have lost patent protection, but warned that allowing novel products to be launched without extensive testing could be dangerous.

The article notes that some drug executives have been vocal about the need for deregulation, quoting Pfizer CEO Ian Read that reducing regulations “will help with drug prices, because it will induce more competition.”

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