Drugs

FDA Product Jurisdiction Reforms Needed: Attorney

Attorney Jeffrey Gibbs (Hyman, Phelps & McNamara) says that how a therapeutic product is classified profoundly affects how it is regulated, and it is time to reform the FDA mechanism for classifying products. Writing in an online FDLI Update, Gibbs says that the two primary problems with the current system are (1) the substantive criteria used by FDA to classify products have evolved in ways that push more products into the pharmaceutical realm and (2) the process by which the agency makes its decisions has become less transparent and less predictable.

The change in classification criteria in a way that favors drug classifications is seen in 2011 draft guidance documents and in litigation over the French company Prevor’s product used to treat skin exposed to chemicals, Gibbs writes.

The article also cites a number of procedural issues that can affect both the outcome of the designation process and the manner in which applicants view the process. Covered are the page limit for a request for designation (RFD) and the Office of Combination Products’ (OCP) refusal to file requests for designation. “OCP started this program without public notification,” Gibbs writes. “OCP has provided no criteria for when it will refuse to file an RFD, leaving applicants in the dark.”

“Although the RFD process can be efficient, it needs to be improved further,” Gibbs concludes. “Transparency and consistency need to be improved. A more formalized and predictable pre-submission process similar to CDRH’s pre-submission meeting program should be established. Beyond procedural reforms, FDA’s criteria for making jurisdictional decisions should be reexamined by FDA and Congress. Improving the product jurisdictional process is an area that warrants further review by Congress and FDA.”

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