Drugs

Bill Would Speed Generic, Biosimilar Entry: CBO

A Congressional Budget Office (CBO) analysis of S. 1895, the Lower Health Care Costs Act, sponsored by Sen. Lamar Alexander (R-TN), says that provisions in the measure would allow some generic or biosimilar drugs to enter the market earlier. The analysis says the bill has several provisions that would modify FDA’s regulatory framework and affect approvals for certain drugs and biologics. “CBO expects that implementing these changes would allow some generic or biosimilar drugs to enter the market earlier, on average, than would be the case under current law,” it says.

One provision would allow the agency to deny a citizen petition if it determines that the petition was submitted with the primary purpose of delaying the approval of an application or if the petition does not raise valid scientific or regulatory issues.

A second provision would allow FDA to approve some generic drug applications that are ready for full approval if no first generic applicant has received final approval and other conditions are satisfied.

Under current law, CBO says, FDA is unable to approve a generic drug application if safety information in the reference-listed drug’s labeling is protected by market exclusivity. The bill would permit FDA to require the affected application sponsors to include a statement of appropriate safety information on the label of the generic drug to ensure safe use, thus allowing the agency to approve the product for marketing.

Finally, a fourth section would create a “private right of action” that would allow developers of generic drugs or biosimilar products to sue manufacturers of innovator products if sufficient quantities of reference samples of their branded product are not made available for premarket testing. The provision also would remove a statutory requirement that manufacturers of generic or biosimilar versions of certain drugs that carry a significant risk of serious side effects use the same risk management system as the innovator drugs to ensure safe use of the product. FDA would be given more discretion to permit manufacturers to use comparable safety systems on a case-by-case basis, CBO says.

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