Timing of Notice, the Patent Dance, and the Supreme Court Ruling

As reported by FiercePharma here, the Supreme Court sided with biosimilar makers regarding the timing of notice to the innovator and agreed that the notice can be accomplished prior to FDA approval of the biosimilar application.  Early notice could provide biosimilar applicants up to a 180-day earlier launch, meaning (obviously) a potentially earlier market entry (should everything go in their favor).

A Banner Month for OGD Approvals

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,

FDA Requests Opana ER Be Removed From the Market.  Will They Fight or Switch?

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.  

High Risk Drug Domestic and Foreign Drug Inspections – Get Ready!

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,

OGD Updates Activities Report of the Generic Drug Program – and Other Tidbits

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. 

Surprise, Surprise – More New ANDA Requirements

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,

Back on Track

 

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. 

Amendment to User Fee Legislation to Expedite Some Generics and Suitability Petitions

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),