Drugs

Assign TE Codes for All Approved Drugs: Study

A USC-Brookings Schaeffer Institute for Health Policy study says FDA delays in approving therapeutic equivalence (TE) codes for some injectable drugs are hurting consumers by slowing competition between branded and generic products. In a blog post, Brookings says that FDA requires injectable drugs to contain, with some exceptions, the same inactive ingredients in the same concentration as the reference-listed drug if they want to obtain marketing authorization through an ANDA.

The report says the sameness requirement can create barriers to entry if inactive ingredients are part of the branded product’s patenting strategy. If generic manufacturers want to get around patents involving product formulation listing inactive ingredients, it says, FDA directs them to the 505(b)(2) pathway rather than the ANDA. However, it says, the 505(b)(2) pathway is under PDUFA rather than GDUFA.

“Unlike with ANDAs, FDA does not automatically assign TE codes to eligible applicants who use the 505(b)(2) pathway,” the report says. “Instead, FDA asks generic companies to file citizen petitions post-approval.”

Brookings looked at 22 such citizen petitions and found that the agency has been very slow to act on them. Many of them are still waiting for a decision, it says, with most having already waited two to three years.

“FDA’s long delays in handling citizen petitions have failed to promote competition, keeping costs higher for customers and purchasers,” the report says. Brookings recommends:

user fee process improvements;
a Congressional mandate to expedite the processing of the reviews; and
greater executive branch engagement to encourage the agency to improve its approach to TE ratings by integrating them into the 505(b)(2) approval process and providing additional budget funds to help with the backlog.

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