Alerts

BakerHostetler FDA and Pharmacy Weekly Digest - January 23, 2019

Alerts / January 23, 2019
Food/Dietary Supplements

FDA Continues Critical Food Programs During Shutdown – Food and Drug Administration (FDA) Commissioner Scott Gottlieb tweeted: “We’ve received multiple inquiries about which critical food operations continue during the shutdown. Examples of the work that we’re still doing include: 1) High-risk domestic food surveillance inspections; 2) Foodborne illness surveillance and outbreak investigations; 3) Execution of high-risk food recalls; 4) Inspection of foreign food facilities; and 5) Sampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis). These are among critical activities ongoing by dedicated, unpaid staff.”

FDA Recalls Workers to Conduct Inspections – On Jan. 20, Gottlieb announced that the FDA has been “recalling inspectors to perform critical, high risk food safety inspections. We’ve been asked how many dedicated colleagues are currently working on these unpaid assignments. More people are on the way.” He also stated that “our Office of Human and Animal Food Operations has more than 200 food investigators (not counting support staff and supervisors) out of about 550 total professionals when the agency is fully operational.”

Drugs/Biologics

FDA Issues Final Guidance on Labeling – The FDA published a final guidance titled “Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.” The guidance is meant to assist in the development of the indication and usage sections for drugs and biological products approved pursuant to the accelerated approval pathway.

Gottlieb Reinforces Support for OTC Naloxone Development – The commissioner released a statement encouraging the development of over-the-counter (OTC) naloxone. Gottlieb stated, “To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA took an unprecedented step: we developed a model DFL [drug facts label] with easy-to-understand pictograms on how to use the drug. We also conducted label comprehension testing to ensure the instructions were simple to follow.”

Gottlieb Announces New Biologics Policy – The FDA commissioner issued a statement about new policies related to development of safe and effective cell and gene therapies. The commissioner stated that the FDA anticipates that “by 2020 we will be receiving more than 200 INDs [investigational new drug applications] per year, building upon our total of more than 800 active cell-based or directly administered gene therapy INDs currently on file with the FDA. And by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.” To meet this demand, the FDA will be expanding its application review group and working with sponsors to increase the use of expedited review programs.

Medical Devices

FDA Announces Latest Steps to Bolster the 510(k) Program – The FDA released a statement on the recent steps it has taken to enhance the 510(k) review and clearance process. These steps include the issuance of a final guidance titled “Safety and Performance Based Pathway.” The FDA is also asking for comment “on steps that we could take to further encourage medical device manufacturers to develop innovations that enhance the safety of 510(k) devices."

Pharmacy

House Oversight and Reform Committee to Address Drug Pricing – The House Oversight and Reform Committee issued a press release saying that it will investigate drug pricing. The committee is seeking information from 12 drug companies about their pricing practices. The committee plans to hold a number of hearings in the near future to obtain additional information about these practices.

HHS Secretary Azar Remarks on Drug Prices – At the Price of Good Health Summit, Health and Human Services (HHS) Secretary Alex Azar remarked that HHS will “continue taking action within the scope of the President’s [drug pricing] blueprint. But if we need to go beyond its four corners to bring down list prices and out-of-pocket costs, we will. This administration is open to working with Democrats and Republicans on these challenges. We are open to any ideas that preserve drug safety and keep the patient at the center. Nothing that meets that standard is off the table until prices come down.”

Authorship Credit: Lindsay P. Holmes

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