United States: FDA and Pharmacy Weekly Digest - December 18

Food/Dietary Supplements

FDA Warns Consumers Not to Use Certain Products Following Consent Decree – The FDA issued a warning to consumers to steer clear of certain drug, dietary supplement and medical device products after the distributor of the products entered into a consent decree and agreed to recall and stop distributing the products.

FDA Provides Update on Romaine Lettuce E. coli O157:H7 Investigation – The FDA recently announced an E. coli outbreak related to certain salad kits. The FDA also stated it has been working with health officials in Washington state regarding an outbreak of E. coli O157:H7 associated with romaine consumption at a local restaurant chain. Washington state officials reported 10 confirmed and three probable cases in this outbreak, with all reports of exposure in early to mid-November. It should be noted that these are currently being considered three separate outbreaks caused by three different strains of E. coli O157:H7.

Drugs/Biologics

FDA Warns Drug Company for Not Listing Adequate Warnings – The FDA issued a warning letter to a company alleging that one of its products was misbranded because the company omitted “warnings about the most serious risks associated with the drug from promotional materials.”

FDA Gives Accelerated Approval to Treatment for Rare Duchenne Muscular Dystrophy Mutation – The treatment is an “injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. It is estimated that about 8 percent of patients with DMD have this mutation.”

Director of the Center for Drug Evaluation and Research Testifies About Securing the U.S. Drug Supply Chain – Janet Woodcock spoke before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. She stated, “In response to the move from domestic to global manufacturing and the passage of FDASIA, FDA’s drug inspection program shifted from one focused heavily on U.S.-based facilities through the early 2000s to a program that, since 2015, has conducted more foreign than domestic drug inspections…. FDA’s drug inspection program is now risk-based. FDA prioritizes for inspection facilities deemed higher-risk based on specific, defined criteria…. Over the past 20 years, the pharmaceutical industry that supplies American patients with drugs has, to a significant degree, moved offshore, so that today the majority of API and FDF manufacturing facilities are located outside the United States. In response, FDA has developed a risk-based approach to surveillance inspections that ensures equal treatment of foreign and domestic facilities. We believe that this is an effective and efficient approach for ensuring that American patients have access to a supply of safe and effective drugs.”

FDA Publishes Drug Development Tools (DDT) Guidance – The guidance “meets the Cures Act’s mandate to issue guidance on this section-507 qualification process and related Prescription Drug User Fee Act (PDUFA) VI commitments; the draft guidance of the same name issued January 7, 2014, is withdrawn. Specifically, once finalized, this guidance will represent the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on taxonomy for biomarkers and other DDTs, and on implementation of section 507 of the FD&C Act with respect to the processes for requestors interested in qualifying DDTs.”

FDA Publishes List of Drugs That Are Off-Patent and Off-Exclusivity and Have No Approved Generic – The FDA stated, “The list includes approved new drug applications (NDAs) for drug products that are not protected by patents or exclusivities at the time of the update, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. Both PDF and Excel formats are available for the current update and all previous updates.”

FDA Comments on New Analysis Demonstrating the Link Between Generic Drug Competition and Lower Drug Prices – The FDA stated, “This new analysis underscores the critical nature of the work the FDA is undertaking to encourage timely market competition from high-quality, safe and effective generic drugs, which can help provide patients with access to affordable therapies that treat a wide range of medical conditions…. The FDA will continue to do all it can to support a robust, competitive generic drug market by helping facilitate a strong pipeline of applications, improving agency processes and providing industry with thoughtful, clear guidance and recommendations to support generic drug development and approval.”

Medical Devices

FDA Authorizes Insulin Dosing Controller – The FDA awarded marketing authorization of “an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery.”

FDA Awards Clearance to Disposable Duodenoscope – The FDA cleared the first fully disposable duodenoscope.

FDA Releases Six Medical Device Guidance Documents – The guidance documents cover premarket approval (PMA) application supplements, 513(g) requests, the medical device eCopy program, PMA annual reports, PMA acceptance and filing reviews, and notifications for manufacturing method or process changes.

Pharmacy

House Passes Drug Pricing Negotiation Bill – The House passed H.R.3, which “requires the Centers for Medicare & Medicaid Services (CMS) to negotiate prices for certain drugs (current law prohibits the CMS from doing so). Specifically, the CMS must negotiate maximum prices for (1) insulin products; and (2) at least 25 single source, brand-name drugs that do not have generic competition and that are among the 125 drugs that account for the greatest national spending or the 125 drugs that account for the greatest spending under the Medicare prescription drug benefit and Medicare Advantage (MA). The negotiated prices must be offered under Medicare and MA, and may also be offered under private health insurance unless the insurer opts out.”

FDA Announces Proposed Information Collection Related to Outsourcing Facilities – The FDA published a Federal Register Notice announcing the proposed collection of information to understand the challenges and opportunities encountered by compounding outsourcing facilities.

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