Drugs

FDA Consumer Health Activities Updated

FDA Office of the Commissioner chief of staff Lauren Silvis says the agency is making progress on several consumer health activities. In 5/21 remarks to the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, Silvis discussed agency activities on OTC monograph reform, the Nonprescription Safe Use Regulatory Expansion program, modernizing regulation of sunscreen ingredients, modernizing dietary supplement regulation, supporting a science-based framework for cannabidiol in food and dietary supplements, and agency initiatives to advance innovation.

She reassured her audience that OTC monograph reform remains a top priority for FDA. The monograph system should be modernized to allow for more innovation, she said, and the OTC reform legislation, which has broad support, meets that goal.

“FDA has long engaged in this effort,” Silvis said, “and we will continue to do so, working with all stakeholders and Congress to make clear that OTC monograph reform is a critical public health priority. It’s in the best interest of patients to modernize the monograph system. That means that FDA will continue to engage on this issue, until we have a system for OTC drugs that provides Americans what they need to better manage their own health care. We know it’s up to Congress to legislate on this issue, but you’ll continue to hear from FDA that OTC modernization will help consumers take charge of their own healthcare, promote safety and innovation, and help Americans lead healthier lives.”

Silvis also said that FDA has received many questions and suggestions from sponsors about innovations that could increase the number of NDA drug products that can be marketed as nonprescription when the drug facts label is not sufficient to ensure that consumers can self-select, or use a drug product, without the supervision of a healthcare practitioner.

“We agree that this is an important opportunity to improve public health,” she said, “and in 7/2018 FDA issued a draft guidance titled ‘Innovative Approaches for Nonprescription Drug Products.’ The draft guidance encourages industry to continue to innovate as they develop and seek approval of certain nonprescription drug products.”

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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