Are FDA and PhRMA guidelines for providing information too restrictive?

We are now in an era of transparency when it comes to medicine and its relationship with the pharmaceutical industry. The Sunshine Act is in place, and the public wants to understand what relationship their physicians have with industry. The pharmaceutical industry is one of the most scrutinized and regulated in the U.S. This regulation does not just apply to industry’s financial relationships with physicians. In addition to regulation of gifts and payments to physicians, industry now is even more restricted on what it tells physicians. Why have we gotten to this point, and has the regulation crossed the line?First, we need to address the issue of giving misleading information. It goes without saying that a company should not be able to make false claims. While there has been much discussion recently about the FDA restricting industry’s right to freedom of speech by restricting what it tells physicians and the public, clearly this does not apply in this situation. Obviously, misleading information and false claims may put patients at risk and should be restricted. But what if the information is not false? This is where the problem lies.

Ocular Therapeutix™ Announces Topline Results of Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Allergic Conjunctivitis

BEDFORD, Mass.–(BUSINESS WIRE)–Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, announced today topline efficacy results from a Phase 3 clinical trial to evaluate the safety and efficacy of DEXTENZA™ (sustained release dexamethasone) 0.4 mg, Intracanalicular Depot for the treatment of allergic conjunctivitis. DEXTENZA is a product candidate administered by a phy


NovaBay Announces Proposed Public Offering of Common Stock and Warrants

EMERYVILLE, Calif.–(BUSINESS WIRE)–NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on commercializing and developing non-antibiotic antimicrobial products for the global eye care market, today announced that it intends to offer shares of its common stock and common stock purchase warrants in an underwritten public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be comple