Back in May 2016, I wrote a blog post (here) about a budgeting proposal put forth by Senator Joe Manchin of West Virginia that would have financed opioid treatment programs by a tax on the opioids themselves. This would eventually have placed higher purchase costs on the patients that needed the drugs.
On Tuesday July 18, 2017, the FDA held a public meeting entitled, “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access”. The meeting’s purpose was “intended to provide the public an opportunity to submit comments concerning administration of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”
While there were a number of presentations which can be accessed through the CDER web site once the transcript is published (see here) the themes of each presentation were very similar.
The Manual of Policies and Procedures (MaPP) 4520.1 entitled Communicating Drug Approval Information, underwent revisions and the new revised MaPP was published today. While it’s current revision history notes the following change – “Decreased the time for webmaster to post change from three to two business days, for approved labeling for drug approvals”, everyone interested in FDA product approval should become familiar with the contents of this MaPP last revised in 2014.
On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations.
During the presentation, I was asked by one participant what I thought the maker of Opana ER would do.
In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the highest total of total approval actions (100) in a month,
With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017. From data gathered from the daily approval report, I find at least 84 full ANDA approvals,
FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers The guidance explains what a product identifier is and how enforcement discretion will be applied.
Appearing in today’s pre-publication of the Federal Register (here), the FDA announced the issuance of an Emergency Use Authorization (EUA) for an atropine autoinjector that has not been FDA approved to date. An EUA is issued by the FDA once a series of requests have been made and cleared for a product for a potential domestic disaster,
Revision 3 of Manual of Policies and Procedures (MaPP) 5240.3 was published today and provides an update to include priority review for ANDAs for which there are fewer than three generic competitors. The MaPP also provides boundaries around when an ANDA will be eligible for priority review by providing a more specific set of conditions,
The Office of Generic Drugs (OGD) updated its Report of the Generic Drugs Program for May to add some additional figures. While there are no real surprises, it is notable to point out that the number of changes being effected (CBE) supplements soared to almost 700 (690), which is by far the largest number of CBE supplements this FY by almost 100.
The Office of Generic Drugs (OGD) has issued a revised Manual of Policies and Procedures (MaPP) updating the new organizational structure and defining where in the CDER and FDA organization reviews of bioequivalence studies with clinical endpoints will be conducted. The MaPP, 5210.4, Rev. 2, makes one thing clear, and that is that the initial review and final sign-off on a biostudy with clinical endpoints will now be conducted within the OGD’s Office of Bioequivalence,
The FDA has published guidance for the submission of facility information that is required to assure the shorter review timeframe for priority submissions. This is a new provision of the GDUFA II negotiation and appears in the Commitment Letter. This pre-submission must be into OGD 2 months prior to submission of the priority application, supplement,
The Congressional Budget Office (CBO) has scored (costed out) additional costs for the provisions of GDUFA II reauthorization over and above the $493.6 million/year (GDUFA II first year fee collection).
The CBO speaks about the additional costs for the new amendments added to GDUFA II, which are believed to be over the fee collection under the program (albeit not clear).
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,