Drugs

Appeals Court Slaps Down FTC in Shire Case

In a decision that may ultimately affect FDA as well, the 3^rd Circuit Court of Appeals has issued a ruling in FTC v. Shire ViroPharma that attorney Jennifer Thomas (Hyman, Phelps & McNamara) says “could set the Federal Trade Commission’s litigation authority back decades.” Writing in her firm’s FDA Law Blog, Thomas says the case involved Shire filing numerous “sham” citizen petitions to FDA and lawsuits against the agency to allegedly keep generic versions of its Vancocin (vancomycin) off the market.

Thomas says FTC prefers to litigate cases in federal court rather than administrative proceedings because the potential for monetary relief is significant. She says the appeals court took the position that Congress intended the relevant portion of the FTC Act cited by the agency to bring its cases against unfair and deceptive practices to be used only while an administrative case was pending. The court, noting that Shire stopped its allegedly illegal practice five years before FTC brought its case, said the law should only be used when a company is violating or about to violate the law, not years after the alleged violations occurred, Thomas says.

“In dicta that is likely to haunt both FTC and FDA in future litigation,” Thomas says, “the 3^rd Circuit also questioned whether FTC’s belated suit against Shire based on the company’s FDA citizen petitions had ‘the potential to discourage lawful petitioning activity bey interested citizens, activity that is protected by the First Amendment.’”

The attorney says that given the bad facts of the Shire case, FTC may decide not to seek a rehearing or to ask the Supreme Court to hear the case. It also could ask Congress to give it additional authority to impose civil monetary penalties in administrative proceedings, additional litigation authority, or additional rulemaking authority.

“Short of action by Congress,” Thomas concludes, “if the Shire decision stands and other circuits agree with the 3^rd, FTC will face a more complicated path to obtaining monetary relief in cases involving past conduct.”

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