Is There Snake Oil in Them Thar Pills?

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.

Back in the Headlines – FDA Updates Bioequivalence of Bupropion Extended-Release 300mg Tablets

On October 3, 2012, the FDA announced its finding that the Impax Bupropion Extended-Release Tablets, 300mg, distributed by Teva, was found to be bio-inequivalent to the reference listed drug (RLD) Welbutrin XL 300 mg Tablets. The firms withdrew their product from the market.
A little over a year later, on October 10, 2013, FDA announced the results of the bioequivalence studies required by four additional companies, Actavis, Mylan, Par Pharmaceuticals, and Watson conducted to confirm a finding of bioequivalence of their approved 300 mg Bupropion Extended-Release Tablets. The studies submitted by Actavis, Mylan, and Par Pharmaceuticals confirmed that their products are bioequivalent to Welbutrin XL 300 mg Tablets. However, the study performed by Watson failed to confirm bioequivalence to the RLD, and the firm has agreed to voluntarily withdraw its product from the distribution chain

Time to Tighten Your Belts and Pay Attention to Quality

This is not the first time that the Office of Generic Drugs (OGD) has issued a guidance document that requires firms to assure that they have essential information in their original abbreviated new drug applications to permit a substantive scientific review.  Remember prior to the 1992 Hatch-Waxman final rule when an ANDA could be submitted with just a bioequivalence protocol and the actual biostudy could be submitted as an amendment? 

Is Part 11 Dead? Part 1 of a series– Electronic Records

Hardly!  But Part 11 (21 CFR Part 11), which applies to records in electronic form and the use of electronic signatures required by predicate rule (i.e., those records required to be signed by GMP regulations), has been scrutinized and discussed among regulators and the industry over the years, and the industry is still waiting on the final revised ruling.

The MaPP to Nowhere!

For those of you who have not yet read MaPP 5200.3 (here).   Responding to Industry Inquiries with Respect to Abbreviated New Drug Application in the Office of Generic Drugs, you better have your CEOs take a Valium prior to your reporting its contents.  In a nutshell, it says you can call us – but only the Regulatory Project Manager (RPM) and the call must be from your single designated industry contact,

Stuck on you – Now in Technicolor

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!

This Road Has Been Traveled Before? Chance of Success Approaching Zero!

IntelGenx Corporation of Saint Laurent, Quebec, Canada submitted petition FDA-2013-P-1058 (here) on August 22, 2013, asking the FDA to designate its Rizatriptan Oral Film product as AB rated (or therapeutically equivalent [TE]) when approved to Maxalt-MLT Orally Disintegrating Tablets, the reference listed drug (RLD) cited in its 505(b)(2) application. The fact that the two products might perform similarly does not overcome the fact that the products are different dosage forms.

Reporting of Serious Adverse Events for Dietary Supplements and OTC Drugs – A Simple Idea

Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required that serious adverse event information be reported to FDA for dietary supplements and OTC drugs not approved through a new drug application. There are many questions that can come up as soon as you dig a little deeper into what is required. Some answers will be provided here, but these are meant only to call attention to the potential complexity and depth of these requirements.

Wait a Minute – Did Everyone Think This One Through?

Oftentimes, over the years when I was working at the FDA, policy decisions were made way above my pay grade that did not really have buy-in from us program folks.  In my further review of the FDA’s Draft Q&A Guidance on the implementation of the new stability requirements, I wondered if program and policy were singing the same tune on the issue of amendments (and supplements) to abbreviated new drug applications (ANDAs) submitted prior to the June 20,