This is a first in a series of posts that will outline some of the more interesting and unique changes that the FDA is making in its Proposed Rule issued last week
Today, the FDA published a Proposed Rule (371 pages!) to amend its regulations and to implement Title XI of the Medicare Modernization Act (MMA). FDA is taking this step because it has been regulation directly from the statute since its passage, but also to facilitate compliance with and efficient enforcement of the FD&C Act, and to clarify and update these regulations based on recent court decisions and our practical experience implementing provisions related to the approval of 505(b)(2) applications and ANDAs.
Well, it’s February 4, 2015 and the “Drug Approvals” page on the FDA website appears to have been updated to include ANDA approvals through January 30, and it substantially below the average approvals per month seen in the last two fiscal years.
Well, we now have the actual numbers for various input and output metrics for FY 2015’s 1st quarter that speaks to the current level of productivity at the Office of Generic Drugs (OGD). So, let’s look at some of the numbers.
I’m not quite sure what brought this long awaited generic approval to fruition but on January 26, 2015, the Office of Generic Drugs (OGD) issued approval for the product.
Dr. Robert Califf was appointed FDA Deputy Commissioner for Medical Products and Tobacco. As such, Dr. Califf will oversee the “Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.”
Lots! Here we are in mid-January, almost one-third of the way through the first GDUFA metric year and year three into the GDUFA program itself. As we have reported previously, CDER is having trouble with its new IT platform and, thus, reporting its statistics to the industry has been difficult at best and, at most, very confusing for anyone outside of FDA.
On January 13, 2015, FDA denied an ANDA suitability petition requesting a change in dosage form from Ibuprofen Chewable Tablets, 100 mg to an Orally Disintegrating Tablet of the same strength. Anyway, FDA must have its reasons, and the Agency’s decision will stand unless the petitioner files a petition for reconsideration.
Well, it’s January 2015 and the Office of Pharmaceutical Quality (OPQ) is about to be stood up (“FDA speak” for official) and will be addressing quality issues across the New Drugs and Generic Drugs arenas. The concept is of one quality voice and one standard, but more about this in a bit. The new leaders of OPQ are outlined in a CDER posting relative to the new organization.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”. This document gives us an idea of what is new and what changes we can expect on various issues over the coming year. It is not specific as far the specific changes that are upcoming, but at least it provides direction as to where changes or new advice may be forthcoming from FDA.
We know that there are a number of approved products that contain caffeine. But now, as noted in a recent article by the Associated Press found on Yahoo health (here), the FDA is gearing up for a legal battle to reduce the availability of caffeine powder being sold as a dietary supplement.
Well, after a lot of talk and years of discussion, “The Food and Drug Administration (FDA) is proposing to amend its labeling regulations at 21 CFR 201.100, 201.306, 201.310, 606.121, 606.122, 610.60, and 610.61 for human prescription drugs and biological products, and blood and blood components intended for transfusion, to require that the prescribing information (commonly referred to as the package insert) intended for health care professionals be distributed electronically and, with few exceptions, not in paper form.”
A December 10, 2014 petition filed by Wiley Rein LLP on behalf of Acura Pharmaceuticals (here) asks the FDA to require Purdue to file an ANDA rather than a 505(b)(2) application for a duplicate version of an immediate release oxycodone tablet with abuse-deterrent properties. The petitioner argues that,because the abuse-deterrent characteristics of the proposed Purdue product are similar to those of its Oxecta product, and because both products are pharmaceutical equivalents, that a firm should not be able to circumvent the listed patents on the Oxecta reference listed drug (RLD).
Just weeks after the Office of Generic Drugs (OGD ) released a revised bioequivalence (BE) guidance for extended-release generic equivalents of Concerta and took action to revise the therapeutic equivalence code for the two generic approved products to BX (non-substitutable/not therapeutically equivalent), OGD released a new fairly onerous draft BE guidance for Budesonide Extended-Release Tablets.