Got Some Time on Your Hands – New Quality Guidance for MDIs and DPIs Issues

On April 18, 2018, the FDA issued a revised draft guidance on Metered Dose Inhalers and Dry Powder Inhalers titled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations Guidance for Industry”.  The original guidance was published November 13, 1998.  The revision spans some 50 pages of discussion about critical quality attributes,

So How is that Prescription Drug Imported On-line from Canada?

With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate.  While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea.  ABC News (here) seem to validate my opposition.

FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions

We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or liquid caffeine containing products.

Outsourcing Facilities Make the News Again

On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here).  Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency.  Today’s announcement highlights a continued sterility assurance concern by the FDA.

Median Actions on Inspections Reported By FDA

Under Section 902 of the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the FDA is required to annually publicly report information regarding certain statistics on inspections of facilities associated with the approval of drugs and devices and the impact that they might have had on delaying applications. The calendar year 2017 report has recently issued and the full report can be found here.

Transparency for Decision-Making Process Coming to an Inspection Near You!

In June of 2017, FDA released a document entitled “Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations.”  This white paper/concept of operations (ConOps) reviews the coordinated operational efforts between the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA).

The anticipated outcomes of the operating model will enable FDA to meet new challenges presented by the complex pharmaceutical industry intricacies. 

AAM Testifies at Opioid Hearing

Today, the AAM is providing written testimony to the Committee on Energy and Commerce Subcommittee on Health addressing Combating the Opioid Crisis: Prevention and Public Health Solutions, the full text of which can be accessed through the AAM website (here ).

The testimony addresses the following major points.

  • It is critical that we combat the misuse of prescription medication while maintaining legitimate,

Flu the Coop!

Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu.  The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms.  In addition, they also warn patients to be wary of online pharmacy sites that may offer unapproved or fraudulent anti-viral products.

Defining Suspect and Illegitimate Products Under the Drug Supply Chain Security Act (DSCSA)

The FDA has issued a guidance (here) that provides clarification on the definitions of suspect and illegitimate products under the  Drug Supply Chain Security Act (DSCSA).  The definitions are designed to help those in the supply chain better and more accurately characterize problem products they may uncover.

The guidance provides the following definitions:

SUSPECT PRODUCT—The term ‘suspect product’ means a product for which there is reason to believe that such product —

(A) is potentially counterfeit,

Compounding Fairness???

As the compounding Industry awaits the next round of Guidances from FDA on using bulk drug substances, one point of controversy appears to be the fairness of compounding for 503A and 503B entities. The most recent Guidances for Compounding from Bulk Drug Substances are:

Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food,

Is There a New Tactic for Generic Manufacturers to Use to Hit a Bullseye?

We have long heard arguments that traditional and Outsourcing compounding entities represent unfair competition to the generic drug industry and that they frequently circumvent the Federal Food, Drug and Cosmetic Act (especially the 2013 Drug Quality and Security Act, DQSA).

A new tactic that has been recently used by a generic firm to protect its approved product was to sue FDA on the grounds that the FDA Interim Policy on compounding using bulk drug substances (APIs) under section 503B of DQSA is contrary to law. 

Thought FDA Was Tempering Back Its Oversight and Enforcement of Compounding Operations? Think Again!

Commissioner Dr. Scott Gottlieb shared FDA’s 2018 Compounding Policy Priority Plan (here) providing an overview of the Agency’s key priorities to implement (and enforce) the federal law on compounding (Drug Quality and Security Act [DQSA], signed into law November 2013). He also states that this plan advances FDA’s mission to protect the health and safety of the public.