On May 16, 2017, we published a blog post on the issue of new and revised bioequivalence (BE) guidances (here) and the impact on industry relative to the potential to have to repeat studies that have already been conducted for pending application or developed products where the ANDA has not yet been submitted.
The month of May 2017 may go down as the true turning point in the Office of Generic Drugs (OGD) review and approval process. If not, it will at least go down as the second highest number of approval actions in a single month since the start of the GDUFA program. OGD reported fully approving 77 ANDAs and tentatively approving 19 ANDAs for a total of 96 approval actions,
In what (I believe) is only the second opioid that FDA is seeking to remove from the market because the risk no longer outweighs the benefits of the product (first was the original formulation of Oxycontin), the Agency said “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.
After slogging through some of the FDA dashboards, I came across one that I felt was worthy of mention. The FDA’s Office of Regulatory Affairs (ORA) has apparently begun the process of scoring drug manufacturing establishments in their risk-based inspection program. The FDA has been talking about risk-based inspection (as well as risk-based review) ever since I was at the Agency,
As reported by FDA WebView (here [subscription required]), FDA announced the appointment of three former congressional staffers Dr. Gottlieb has chosen to add to his current team, as his team builds his vision for the Agency is becoming more clear. And it is not the usual vision we have seen from past commissioners.
Despite great efforts by the FDA and the industry, there still are 55 different drug products under shortage on the FDA’s list (here). While the number of drugs on the shortage list is much lower than we have seen in the past (100+), there is still cause for concern as products move on and off the list.
The Office of Generic Drugs (OGD) has provided additional updates to its April 2017 metrics, as reported in the above-referenced document. Not much excitement there but notable for another low month of Refuse-to-Receive (8), which should be good news to industry. In addition, Drug Master File (DMF) reviews hit a low for this fiscal year at 44.
At the Association for Accesible Medicines (AAM) CMC workshop last week, the issue of first cycle was on a lot of people’s minds. Industry and FDA realize that the only real way to cut down on FDA workload is to get it right the first time. Industry continues to say with the constantly changing requirements and FDA expectations,
Anyone contemplating submitting a drug-device combination product like an autoinjector, prefilled syringe, transdermal patch (yes, transdermal patch), etc., should be prepared to address some of the device regulations or you will likely get a deficiency letter. (To be perfectly honest, if you get these deficiencies, I think you should push back on the FDA, but that is an individual decision you must make.)
FDA has been asking to address 21 CFR 820.20,
Well, things do change in Washington these days on a minute by minute basis and the news cycle continues to amaze even the most skeptical of viewers. Seems like the User Fee Reauthorization is back on track after the House Energy and Commerce Subcommittee rejects the call of the Secretary of HHS to reopen User Fee negotiations.
With the User Fee negotiations complete, agreed upon by both FDA and industry and proposed bills ready for mark-up, it appears that now the Secretary of the Department of Health and Human Services (DHHS), Tom Price, is requesting that Congress consider raising the negotiated and agreed upon fees to be in line with the Trump budget.
The FDA today announced the addition of 21 new and 16 revisions to existing bioequivalence guidance documents. The Agency continues try to keep ahead of the curve relative to the timing of the issuance of guidance but, at the same time, is making pronouncements for some very old products as well.
Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill. However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective.
The Amendment, which was paired down to remove some of the objectionable and potentially congressionally unpalatable and Agency unworkable issues (like expedited review in 150-days for certain ANDAs subject to drug shortage and where there was limited competition),
With Scott Gottlieb, M.D., winning confirmation to head the FDA yesterday, the Agency is ready to move forward to the beat of a different drummer. It will be an interesting ride and we will watch it along the way. It also looks like the User Fee legislation may make its way to law, as it looks like the last hurdles have been cleared.