Drugs

Comments on Therapeutic Equivalence Draft Guidance

The Association for Accessible Medicines (AAM) says it appreciates FDA’s efforts in providing a draft guidance on therapeutic equivalence (TE) evaluations and the assignment of TE codes. The AAM says its members have suggestions for how the draft guidance can provide even more transparency into FDA’s TE evaluations and improve the processes for making these determinations to bring more competition to the market and provide greater patient access to therapeutically equivalent generic drugs. Its comments address (1) assigning TE ratings to products approved in a 505(b)(2) application; (2) changing or removing TE ratings; and (3) TE ratings based on packaging.

In its comments, Apotex recommends that FDA “align itself with the more extensive definitions of TE that the European Medicines Agency and Health Canada have undertaken, within the spirit of international harmonization for generally-aligned regulatory bodies, for global convergence, and to encourage more competition for the same active pharmaceutical products with therapeutic equivalence, which in turn will result in lower prices for customers, payors, and government purchasers.”

Amicus Therapeutics raises a specific question about a potential conflict between a carve-out in the label of an A-rated generic and the regulatory definition of therapeutic equivalence. “We believe this conflict is particularly likely if a generic label omits some portion of the reference-listed drug’s sole information because it is protected by a patent,” Amicus says.

Teva highlights points in the draft that could be improved to ensure even greater patient access to TE-rated generic alternatives. It says FDA should:

not remove TE ratings from the Orange Book once they are assigned, even if a drug becomes single-source;
explain when and for what reason it would revise a TE rating from AB to BX;
assign TE ratings for eligible 505(b)(2) products as part of the review process and should not require a citizen petition to obtain a TE rating for those products; and
be explicit about what aspects of packaging would affect a TE rating for generic combination products.

Cipla provided several specific comments.

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