37 Compounding Pharmacies Currently Registered as Outsourcing Facilities

As of April 11, 2014, the FDA has received and processed requests for 37 compounding pharmacies as outsourcing facilities. In October 2014, outsourcing facilities will be required to pay a fee. The fee schedule will be published in August 2014, and any facility that registers on or after fees are due will have to pay the registration fee at the time of registration.

MDI and Dose Counters – FDA Reaffirms Position

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.

Half Way Through FY 2014 – A Look at ANDA Submissions and Approvals

Six months into Fiscal Year 2014 and some staggering submission numbers should send a chill up the old OGD spine. So far, this FY OGD has received 597 new original ANDAs based on numbers released on April 11, 2014. That number reflects activity through the end of March 2014. On the other hand, OGD has approved 392 ANDAs in the first 6 months of this FY. So let’s look at the numbers a bit more closely.

OMG – Omega -3 ANDA Gets Approved!

OGD approved another “complex” drug product and brings a happy closure to an ANDA submitted in November 2008. By no means a record in terms of length of approval, this ANDA has been percolating for 65 months since submission and represents another in a string of complex products that OGD has tackled and approved. Thus, the first generic for Lovaza will likely hit the market soon as Teva’s ANDA # 091028 for Omega-3 – Acid Ethyl Esters gained approval on April 7, 2014.

Big Decisions Loom in 2014 for Generic Applicants

There are a number of dilemmas looming over generic drug firms in 2014 – some with no easy answers, but hopefully firms are considering their choices sooner rather than later. Two of these issues relate to the all-important question “Exactly when should the ANDA be submitted?”. Any generic drug firm knows that that answer is never easy and is dependent on many factors, such as biostudy success, completion of stability testing, facilities being ready for inspection and first-to-file opportunities, just to name a few. And of course, such practical scientific or regulatory deadlines are further complicated by the directed business goal of “the sooner the better”.

Two Watch Outs That May Cost You Dearly!

In trying to read the tea leaves at the Office of Generic Drugs (OGD) and discussing issues that really worry both OGD and industry, I have come across two issues that you need to stay on top of, one during the approval process and the other just after ANDA approval, to avoid a potential delay in approval that you did not see coming or a potential change in the way OGD does business relative to ANDAs subject to the valuable 180-day exclusivity provisions of the Act.

Who’da Thunk?

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.

Warning Letters Continue for Compounding Pharmacies – FDA Cites Five in 2014 So Far

The FDA has stepped up its surveillance of compounding pharmacies and has issued at least 5 Warning Letters to such establishment so far this year. The beat goes on, and now the FDA must begin to integrate with the State Boards of Pharmacy and State Drug Inspectors to determine the evolving definition of what is a compounding pharmacy and what is an “outsourcing” compounding pharmacy.

Revised ANDA Checklist – The New Requirements Keep on Coming

For those of you that may have missed the January 2014 revision of the ANDA Checklist (last revised was 3rd quarter, October 2013), there are some new items that FDA will be looking for in its initial Completeness and Acceptability Review of ANDAs. Failure to include this information could result in a Refuse-to-Receive letter and a penalty of 25% of your ANDA user fee.

OGD’s Paragraph IV Database and Two Interesting Listings

The Office of Generic Drugs (OGD) updated its Paragraph IV Database (PIVDB) yesterday and two new entries caught my eye. An ANDA for glycerol phenylbutyrate oral solution (a copy of the NDA for Ravicti held by Hyperion Therapeutics) was listed as submitted on November 19, 2013 and posted on 3/10/14 or about 4 months after the original submission. In this case, it is not the length of time the ANDA has been at OGD, but rather the exclusivity and patent issues associated with the product and the jump on first-to-file status that at least one generic firm has decided to seek, especially since the original NDA was approved on February 1, 2013, only 9 months prior to ANDA submission. The second listing that got my blood flowing was for Memantine Hydrochloride extended-release capsules, a generic form of Namenda XR Capsules. There was an approximate 10-month period from submission to acceptance of the ANDA. While that is not the longest review time for completeness and acceptability we have seen, it certainly indicates that either OGD had a difficult time evaluating the ANDA for receipt (maybe bioequivalence issues?) or their backlog could be a factor.

A Little Late, But CMC Annual Reportable Postapproval Changes Guidance Hits the Street

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.

GPhA Testimony on FDA’s Proposed Label Rule – Hearing Delayed but Democrats Balk

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.