Leave it to the FDA!

Just three days before Thanksgiving, the FDA issued two Final Rules requiring caloric content on menus and food from vending machines. While the Rules go into effect in a year for menu items and 2 years for food from vending machines, release of the Final Rule just before the holiday makes me cringe.

Transparency Window Shuts Further At OGD – Hopefully Only Temporarily

We are almost two months into FY 2015 and the first year of metrics for GDUFA, but have you noticed that the Generics Activity Report of the Generic Drug Program has not yet published for the October? As we understand it, the new OGD/CDER IT platform, noted by Dr. Woodcock as having some problems at the GPhA Fall Technical Workshop, is perhaps the culprit.

Here’s a Shock – Alpha Male Contains Undeclared, Hidden Drug Ingredient

Today, FDA issued a Public Notification indicating that the supplement Alpha Male, marketed with a tag line of “Knock it out of the Park with Alpha Male!” contains derivatives of both tadalafil (the active ingredient in Cialis) and derivatives of sildenafil (the active ingredient in Viagra). This is just another in a long line of supplemental products containing adulterants that makes them not only new drugs, but also dangerous.

Someone Won the Race for Abuse-Deterrent Hydrocodone Bitartrate Single Ingredient Tablets!

With all of the publicity (mostly negative) about the approval of the first (non-abuse-deterrent) hydrocodone bitartrate single entity extended-release (ER) product, Zohydro, by Zogenix, the race was on for the development of an abuse-deterrent formulation. On November 20, 2014, Purdue Pharma won that race with the approval of Hysingla (hydrocodone bitartrate) ER-Tablets with abuse-deterrent properties. Purdue obtained approval for 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100mg, and 120 mg tablets.

FDA Annual Report Reviews Delays and Activity for 505(q) Petitions

The FDA has released its 2013 report to Congress regarding delays caused by 505(q) petitions. As most of you know, a 505(q) petition was created by Food and Drug Administration Amendments Act (FDAAA) of 2007 to require certain response times to petitions submitted to the FDA that would potentially delay the approval of a 505(j) or a 505(b)(2) application. Congress took this action because FDA response times to Citizen Petitions sometimes took years and industry complained that these delays in response caused delays in approvals for ANDA and (b)(2) applications.
FDA has done very well since the FDAAA in meeting the timeframes for response.

What Price Could the Public be Paying for the Slow Down in Generic Drug Approvals?

CBS Morning Rounds recently ran a piece on the soaring cost of certain generic drug prices. Despite the potential divisiveness of the topic, the piece was very balanced…The CBS piece cites potential reasons certain price increases have occurred as a decrease in the amount of competition for a particular drug product, temporary exit from the product market due to manufacturing problems, or decreases in the supply of active ingredients.

Rx vs OTC- the Debate Continues

On November 12, 2014, the FDA responded (here) to a September 23, 2014 correspondence to Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research and also submitted the same to Docket No. FDA-2012-P-0566 regarding the safety of PEG 3350 for pediatric patients. The big debate is a bit broader than just pediatric safety; it involves an Agency determination stating that, when a product is completely switched from prescription to OTC status,, the product can no longer be marketed by prescription.

Done and DUNS!

After years of FDA assigning unique establishment numbers to FDA inspected facilities, the Agency has published a procedural Guidance today entitled, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration: Guidance for Industry”, identifying their choice of the Data Universal Numbering System D-U-N-S (DUNS) number, assigned and managed by Dun and Bradstreet.