Drugs

9 GA Congress Members Want Chemo Transparency

Nine bipartisan members of Congress from Georgia, led by Sen. Raphael Warnock (D-GA) and Rep. Earl Carter (R-GA), are asking FDA for information on the agency’s response to the continuing shortage of chemotherapy drugs and what it is doing to ensure the safety of imported replacement drugs. In an 8/24 letter to FDA commissioner Robert Califf, the nine say they have heard from patients and doctors across their state who are confronting the shortages.

“Providers at cancer centers have started to alter treatment programs and delay preferred therapies due to limited drug availability,” they write. “Cancer hospitals in Georgia are currently tracking several drugs other than cisplatin as limited in supply, including carboplatin, fludarabine, fluorouracil, methotrexate, dacarbazine, idarubicin, and Bacillus Calmette-Guérin. Georgia cancer patients and their doctors deserve to choose treatment based on best evidence and what works for the patient without the additional burden of worrying about the availability and safety of drugs.”

The nine say that while they are pleased FDA is acting to mitigate the shortages, including working with additional manufacturers to increase drug supply, they are concerned about the lack of agency transparency about the suppliers, especially since FDA has begun importing cisplatin injections from Qilu Pharmaceutical, which is not FDA-approved and manufactures the injections in China. They also say they are concerned about the lack of a timeline and any new detail on when new, safe imports of carboplatin will begin and from where they will be imported.

The letter asks for responses to these questions:

how FDA is working with Intas Pharmaceuticals and its Accord Healthcare subsidiary to quickly and safely reopen the production plant in Ahmedabad, India, and whether there is a timeline for Intas to resume production;
the status of the agency’s engagement with additional drugmakers outside of Qilu Pharmaceutical about importing chemotherapy drugs;
how FDA is ensuring that any chemotherapy drugs that are imported to the U.S. meet U.S. drug safety standards;
what FDA is doing to resolve shortages of other chemotherapy drugs outside of carboplatin and cisplatin; and
how Congress can address the root causes of drug shortages, particularly those affecting chemotherapy drugs, so that a future closing of one manufacturing facility will not affect half the U.S. supply of a critical drug.

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