Drugs

Suggestions on Dietary Supplement Innovation

Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should reaffirm and reinforce the statutory distinction between drugs and dietary supplements as established in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Responding to an FDA request for comments on responsible innovation in dietary supplements, PhRMA says that failing to preserve the statutory distinction would be inconsistent with the law’s structure and design, would expose the public to potentially unsafe and/or ineffective products, and would create disincentives for drug development and innovation, such that the therapeutic benefit of certain substances may never be realized.

PhRMA called on FDA to: (1) take action against dietary supplement companies marketing products with synthetic substances that do not qualify as “dietary ingredients” under DSHEA; and (2) take action against dietary supplement companies marketing products with an article that is excluded from the definition of dietary supplement by the exclusionary clause.

The Pew Charitable Trusts comment letter says that “innovation in the dietary supplement marketplace must not compromise safety, yet dietary supplements can pose a range of safety concerns.” The letter urges FDA to take several specific steps to incentivize wide use of the new dietary ingredient notification process, which it says could improve safety and spur introduction of new dietary ingredients.

In its comment, the Consumer Healthcare Products Association says FDA’s policy position on the DSHEA phrase “dietary substance for use by man to supplement the diet by increasing the total dietary intake” is the greatest hurdle with respect to product innovation in the FDA 2016 draft guidance and one of the most inconsistent positions FDA has taken against the intent of DSHEA. “The U.S. Congress inserted a separate definition for non-food ingredients in order to anticipate expansion and innovation in dietary supplement development,” it says.

Comments from the Biotechnology Innovation Organization echo the requests made by PhRMA.

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