Compliance

Today, FDA announced the issuance of a 137 page Proposed Rule designed to investigate whether antibacterial hand soaps are any more safe or effective than washing with simple bar soap. FDA is taking this action to evaluate the safety and effectiveness of these products due to the continued concern about the potential development of bacterial resistance from the widespread use of these agents. The Proposed Rule does not cover does not cover hand sanitizers, wipes or antibacterial products used in the healthcare setting. Rather, it is targeted towards the multitude of bar and liquid soaps used by consumers in routine daily hand and body washes that are advertised as, and contain an antimicrobial agent.

Over the weekend, the President signed the Drug Quality and Security Act, which deals with both Pharmacy Compounding and Track and Trace provisions for all prescription products. The FDA was ready and issued three Draft Guidance documents covering various compounding issues.

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) noted that her vision of the reorganization for the Center is to have “one voice for quality across all drug products including biotech.” She also indicated that while this has been a need of CDER for a while, she gave GDUFA credit as a major driver of this current effort.

On October 24, 2013 the FDA announced its intent to recommend to the Drug Enforcement Administration (DEA) that Hydrocodone-containing combination products be rescheduled into the more restrictive Schedule II. Such a move will make it more difficult for patients to obtain the products, as well as for healthcare practitioners to prescribe these products.

Not that it is a big surprise to current users (at least we hope not), but the FDA announced on October 23, 2013 that they were completing the phase-out of all medical inhalation products containing chlorofluorocarbons (CFCs) by December 31, 2013.

In a recent enforcement action against a dietary supplement manufacturer James G. Cole Inc. (here), the FDA is seeking a Permanent Injunction based on repeated violations of cGMPs and distribution of unapproved drugs. This type of “health fraud” dates back to the days of the traveling medicine men in their covered wagons selling dangerous concoctions of different herbs and drugs and making all kinds of wild health claims for products like Doctor Feel Good Elixir.

On October 11, 2013, the FDA made history by approving Nasacort Allergy 24H, an over-the-counter (OTC) version of the Rx Nasacort AQ (triamcinolone acetonide), a nasally inhaled glucocorticoid for allergy relief.

If you are a developer of apps for a mobile platform, are your apps medical devices, and if so, what requirements do you need to meet? The answer took FDA 43 pages to lay out in their new Guidance for Mobile Medical Applications, which was issued on September 25, 2013. And the answer is, well, it depends!

Today, the FDA announced a change in labeling requirements for all Fentanyl Transdermal Systems in an effort to prevent inadvertent overdose. FDA is also warning patients and caregivers to dispose of patches properly, and warning that patches that do not adhere properly to the patient might fall off and accidentally adhere to another person, such as a child or a caregiver, or even a pet, and, based on the amount of drug left in the patch (should this occur), could cause death!