Obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit despite their risks may get speedier U.S. approvals under plans being discussed to better balance innovation and safety.
Johnson & Johnson and rival makers of transvaginal meshes told Food and Drug Administration advisers they agreed on the need for more safety studies of the implants as well as labeling changes to warn of potential risks.
Congressional talks to renew the fees drugmakers pay to fund Food and Drug Administration reviews include proposals to fast-track evaluations of medicines for conditions with no approved cures, according to two U.S. Senate aides.
Makers of vaginally implanted surgical meshes, led by Johnson & Johnson, may have to conduct studies of three years or more on the products if the Food and Drug Administration follows an advisory panel’s lead.
Arena Pharmaceuticals Inc. rose as much as 26 percent after the U.S. Food and Drug Administration said it “regrets” the lack of an animal toxicity expert on an advisory panel that rebuffed the obesity drug lorcaserin.