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The FDA appears to be adopting a less paternalistic approach to regulating direct-to-consumer (DTC) advertising, according to FTC Commissioner Thomas Leary.
The FTC is urging a federal appeals court to reverse a lower court’s dismissal of generic firm Teva Pharmaceutical’s filing challenging the validity of Pfizer’s patent for the antidepressant Zoloft (sertraline HCl) in a case that could clarify the controversial declaratory judgment provision of last year’s drug patent law.
Federal regulators have approved Merck’s acquisition of privately held biotech company Aton Pharma, clearing the way for Merck to re-enter the cancer drug market after a 34-year hiatus.
The FTC is considering ways to ensure that brand firms do not apply a new legal delay tactic against generic competition that uses the fear of crippling financial damages to prevent generic products from coming to market.
The generic drug industry can’t do much about a new legal-delay tactic brand companies are considering using against generic competition which employs the fear of crippling financial damages to prevent them from launching products, according to the head of the FTC.
Both brand and generic drug interests have urged the U.S. Supreme Court to review an appeals court decision that found a 1997 patent settlement agreement between generic firm Andrx and brand firm Aventis automatically violated antitrust laws.
Drugmakers’ consumer education, disease management and patient compliance websites that allow individuals to submit private information can expose manufacturers to FTC enforcement actions if security measures are insufficient, according to an FTC attorney.
The U.S. Supreme Court is considering whether to review an appeals-court decision that found a 1997 patent settlement agreement between generic firm Andrx and brand firm Aventis automatically violated antitrust laws.
The FTC and the Justice Department have asked parties who filed electronic comments on the agencies’ joint hearings on healthcare and competition policy last year to resubmit them due to technological problems that prevented the original filings from being received.