Drugs

Current Merger Enforcement is Working: PhRMA

Pharmaceutical Research and Manufacturers of America (PhRMA) says the current methods used by the Federal Trade Commission (FTC) and Department of Justice (DoJ) to evaluate proposed drug company mergers are working well as demonstrated by FDA statistics. In its comment letter, PhRMA says the level of innovation output of drug companies has remained high over time. The three-year average of NDAs and BLAs approved by FDA rose from 24 in 2010 to 53 in 2020, it says. And research and development as a percentage of sales increased from 21% in 2006 to 35% in 2018.

“PhRMA recognizes that mergers in the pharmaceutical industry do sometimes present competitive issues that are appropriately addressed through antitrust enforcement, including issues related to innovation competition,” the letter says…. “PhRMA supports transparent, industry-neutral guidance articulating the standards that FTC and DoJ will apply in assessing proposed transactions to help companies avoid lengthy, complex merger reviews and/or craft appropriate remedies to address issues that may arise. With respect to analyzing innovation competition, PhRMA submits that current merger guidelines provide ample flexibility for the agencies to investigate the full extent to which mergers may harm innovation and, therefore, do not need to be amended.”

PhRMA cautions that there would be severe negative consequences if the agencies created economically unsound or ambiguous standards for evaluating pharmaceutical mergers and their effects on innovation. “Uncertainty and unwarranted enforcement actions would prevent smaller and emerging firms from bringing their new discoveries to market. Investment in these innovative companies would fall. Fewer products would obtain FDA approval, competition in pharmaceutical markets would be reduced, and consumers would be harmed. Patients who otherwise would have benefited from new drugs and treatments would suffer.”

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