Drugs

‘Preventable Deaths’ Due to FDA: Analysis

A Goldwater Institute investigative report, “Studied to Death: FDA Overcaution Brings Deadly Consequences,” says the result of an FDA fear that regulators might miss something and be subject to congressional and media criticism is “more preventable deaths and more diseases that go untreated because of a regulatory system that emphasizes caution over innovation and statistical certainty over getting new and effective treatments to patients as quickly as possible.” The report quotes former drug company executive Joseph Gulfo as saying that agency leaders have taken it upon themselves to change the requirements for drug approvals, demanding more studies, more tests, and more time.

Instead of having to prove a new treatment is safe for its intended use, the report says, FDA now reviews drugs based on how they might be used by doctors to treat individual patients, effectively substituting the judgment of agency regulators for that of practicing medical professionals.

“FDA is the lightning rod when anything goes wrong with an approved drug,” Gulfo says. “So the easiest thing to do is to then look for more and more proof that the drug is wonderful, to require higher and higher standards, and longer and longer trials. What that does is dissuade innovation.”

The report says one encouraging sign that change is coming is the passage of the so-called Right to Try legislation that was signed in May by President Trump. (The bill was long championed by the Goldwater Institute.)

Next steps toward change, the report says, could be some sort of conditional approval program in which once the safety of a drug is established in early clinical trials and it shows great promise of being effective, it could be conditionally approved for marketing and used to treat patients. The patients would be intensely monitored for any safety issues and to gauge the drug’s effectiveness.

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

Read more

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