The Creates and Restoring Equal Access to Equivalent Samples Act of 2016 (CREATES) (summary of the Act can be found here and the full Act here) is designed to stop the abuse of the restricted distribution systems and Risk Evaluation and Mitigation Strategies (REMS) programs. How do these two things impede generic access?
With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action. This also obviously assumes that the facility is operating in accordance with the appropriate controls by state or federal agencies.
Just two days after our Tentative Approvals and Receipts post (here), the Office of Generic Drugs (OGD) partially updated its Activities Report of the Generic Drug Program 2016 to include May approval statistics and new ANDA receipts.
OGD approved 54 ANDAs and Tentatively Approved 20 ANDAs. (The FDA Monthly approval site still has listed only 47 approvals and 16 TAs a discrepancy of 13% and 20% respectively).
Information on the FDA’s Monthly Approval Report (here) is usually not complete. Typically, there may be up to a 5-10% discrepancy (lower than actual) in the numbers of Approvals and Tentative Approvals reported. The discrepancy improves over time but seldom do the numbers actually match the reported number of approval actions on the Activities Report of the Generic Drug Program for the same month.
Led by Senators Orin Hatch and Edward Markey with sign on by 20 other senators, a letter to Sylvia Burwell, the Secretary of Health and Human Services (HHS), encouraged an increase of the number of patients a single physician can treat in a Medication Assisted Therapy (MAT) program from the current 100 patient limit to 500 patients.
Today, the FDA announced the availability of a draft Guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications” (here). The document discusses the way in which sponsors should document the adhesion of their proposed product with that the of reference listed drug (RLD).
We have all read about the issue of pay-for-delay, where a generic company gets something in return for a patent settlement and agrees not to market a product for a period of time. The Federal Trade Commission (FTC) is aggressively pursuing such cases as anticompetitive,but that is a topic for another day. Now we may have a pay-for-pain proposition floating around Congress.
Back in December 2013, I wrote a blog about antibacterial hand soaps (here) that still rings true today after the announcement of a superbug that is resistant to all antibiotics. In that post I wrote:
“For years, we have heard scientists voice their concern relative to the widespread use of antimicrobial in the home and non-healthcare settings.
Is there a reason to believe that the emergency contraceptive levonorgestrel (LNG), most popularly known as Plan B, may not be as effective in women that weigh more than 165 pounds or have a body mass index > 25kg/m2? According to FDA in a Question and Answers document (here) posted on the Center for Drug Evaluation and Research (CDER) webpage yesterday,
There are obviously two schools of thought on the Proposed Rule that would permit generic companies to unilaterally update their labeling to include new safety information. On the consumer advocacy side, and from FDA’s view, it will improve patient safety (but personally I don’t see how). But when you look at the Proposed Rule (as we have done here,
In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products. This information was taken from OGD’s Generic Approval reports (here) and navigating to 2013’s First-Time list (here).
The debate about whether prenatal vitamins are a medical food seems to have been clearly addressed once and for all in a revised Question and Answers Guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition” (here). Among other issues addressed in the Q&A document, FDA clearly states its position that prenatal vitamins are not considered to be medical foods.
I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle. But I think I’ve got it now, and I hope I am right! The way the “backlog” used to be counted pre-GDUFA was simply ANDAs that were pending at OGD.
We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?
In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process.
FDA notes that, while overall aspects of the drug, biologics and device review process are funded in part by user fees,