Gottlieb's FDA

The heads of two major dietary supplement lobbies support establishing incentives for the dietary supplement industry, including the possibility of exclusivity, but they are adamant such incentives should not mirror exclusivity as it exists in the prescription drug space.

FDA has ordered surgical mesh for transvaginal repair of pelvic organ prolapse (POP) manufacturers Boston Scientific and Coloplast to stop selling and distributing the products, the agency announced Tuesday (April 16).

FDA took several steps towards ramping up its regulation of dietary supplements on Tuesday (April 16), when the agency launched a list of unlawful dietary supplement ingredients and sent warning letters to 11 companies for using ingredients that either do not meet the statutory definition of a dietary ingredient or for which the company had not sent in a new dietary ingredient (NDI) notification.

Sources say a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress -- could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.

FDA on Thursday (April 11) finalized a decision that 28 active ingredients are not allowed to be used in over-the-counter hand sanitizers -- also known as OTC consumer antiseptic rubs -- and deferred making a decision and called for more data on three other active ingredients, including ethyl alcohol, which the agency says is the most commonly used ingredient in hand sanitizers.

House Agriculture biotechnology subcommittee Chair Stacey Plaskett, who represents the U.S. Virgin Islands, said the subcommittee will spend the beginning of Congress’ term making sure FDA and the U.S. Department of Agriculture (USDA) are on track to have cannabis regulations in place.

FDA is requiring changes to the prescribing information for all opioid analgesic medicines used in the outpatient setting to provide more information about how health care providers can safely decrease the dose in patients who are physically dependent on opioids, the agency announced Tuesday (April 9).

FDA will consider the extent to which a drug’s intended population is expected to use the product for off-label uses when deciding whether to require a risk mitigation program for certain drugs, a policy the brand industry had alleged may exceed the agency’s statutory authority.

FDA and Customs and Border Protection (CBP) signed an agreement Thursday (April 4) to expand how information is shared between the two agencies and coordinate shared space to target entry of illicit drugs coming into the country through international mail facilities (IMFs).