Compliance

The issue of when to apply FDA Draft Guidance has always been a bit confusing and sometimes an amusing subject. FDA Guidance (whether in draft or final form) is supposed to represent the FDA’s current thinking on a specific matter. If the Draft Guidance is newly issued and is still within a reasonable comment period, then it may be best to contact FDA to see if the Guidance is likely to change. Sometimes you can look at the comments submitted to the appropriate Docket to see if there appears to be controversial issues raised by the industry or other government components. The real problem comes when a Draft Guidance is issued and the comment period has passed and months or years go by where the Guidance just sits there in limbo before being finalized.

Just when you thought you got it all done, it is time to do it all over again. FDA announced that the new self-identification for facilities named in a generic drug application will begin again soon.

On April 10, 2014, FDA responded to a petition from Teva Respiratory LLC approving it in part and denying it in part. Teva requested that FDA refuse to approve any rescue inhaler (generally metered dose inhalers (MDIs) of short-acting beta agonist like albuterol), brand or generic, unless it has a dose counter, and that FDA implement a plan to transition all currently approved rescue inhalers to versions incorporating a dose counter.

At the outset of the generic drug scandal uncovered in the late 1980’s FDA developed an administrative Application Integrity Policy. At or about the same time, legislation (the Generic Drug Enforcement Act [GDEA] of 1992), provided for debarment of individuals convicted of certain misdemeanor or felony offenses. During the generic drug scandal, there were 22 criminal convictions of drug companies and 70 convictions of industry and FDA personnel as well as $50 million in fines levied against these organizations and individuals. Eventually there were some 70 individual debarment actions relating to the shenanigans that occurred but to date no firm has been debarred under the provisions of the GDEA. I thought it might be interesting to see what the number of debarments looked like over the last few years.

In a follow-up to my post on this issue early this morning, GPhA announced that 21 pharmacy groups were signatory to a letter to Commissioner Margaret Hamburg, imploring her to reconsider the Proposed Rule on labeling changes in its current form.

The good news is that there is some regulatory relief for the down-regulation of some changes from supplements to Annual Report notifications; the bad news is that the industry will likely spend as much time figuring out the Guidance and trying to position changes such that they can reasonably be read to be covered by the document as trying to get a Regulatory Project Manager on the phone at OGD.

The FDA’s Proposed Rule Supplemental Applications: Proposed Labeling Changes for Approved Drugs and Biological Products occupied the podium time of many speakers at this year’s GPhA Annual Meeting and was clearly on the minds of all attendees. Ralph G. Neas, CEO and President of GPhA, was to testify before the House Energy and Commerce Subcommittee on Health on Monday March 3 to explain just what a detrimental impact on the generic industry the Proposed Rule, as currently written, will have on the generic drug industry, patients, and healthcare providers. Unfortunately, the weather postponed the hearing. An article in Insidehealthpolicy.com today was entitled “Democrats: Concerns About Drug Costs Under FDA Generic Labeling Rule ‘Unfounded’”. Well those Democrats should get off Capitol Hill and get out to the drug companies, the pharmacies, talk to healthcare providers instead of speaking or listening only to the Plaintiff’s bar.