The Lachman Blog

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.

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.

With an anemic start to the month (only 3 ANDA approvals through 10/26/14), the Office of Generic Drugs (OGD) kicked it into high gear during the last days of the month to end the month with 31 total final ANDA approvals.

Remember when you only had to call to OGD to get ANDA statuses? Remember when these was a chemistry contact, a bioequivalence contact, a labeling contact, and a micro contact? Well, now, not only do you have to try to figure out who your contact is, but what you can all them about. The regulatory Project Manager in the Office of Generic Drugs is your primary point of contact for your ANDA. But now you also need to know who your “Quality” contact is in the Office of Pharmaceutical Quality’s (OPQ) Office of Programs and Regulatory Operations (OPRO). In addition, you need to learn a whole bunch of new acronyms!

A number of presenters from Office of Generic Drugs (OGD) at the GPhA Fall Technical Workshop noted that “We have listened to what you have said and we hear you” and have indicated that MaPP 5200.3 that addressed communication with industry (see previous post here) will be revised. Industry representatives have indicated that the transparency in the communication with OGD is something that is essential to being able to make reasonable business decisions in a timely manner and are needed to appropriately run their business organization.

In a presentation to the Generic Pharmaceutical Association Fall Technical Workshop today, Dr. Janet Woodcock, Director, Center of Drug Evaluation and Research (CDER), told the audience that the new CDER quality initiatives under GDUFA are designed to have an Integrated team review to Chemistry Manufacturing and Controls, microbiology, dissolution and inspections through the new Office of Pharmaceutical Quality. The inclusion of dissolution review appears to remove that assessment from the bioequivalence review within the Office of Generic Drugs’ (OGD) team.