Ozone-Depleting Final Rule Escapes Freeze

In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date of February 23,

Cook Serves Up Numbers and Observations

Dr. Kathleen “Cook” Uhl, Director, Office of Generic Drugs told the story of the past, present, and future of GDUFA and how the industry and OGD are doing.  Interestingly, she noted this was the first meeting she had attended where she heard that industry members said they are happy!  Then she noted “you are not really happy,

Association for Accessible Medicines –  What is This?

Today, at the Generic Pharmaceutical Association (GPhA) Annual Meeting, Chip Davis, the CEO of the “former” GPhA announced the rebranding of the association to its new name, the Association for Accessible Medicines (aam).  The change is designed to further the work of the industry group to provide more affordable medicines in both the generic and biosimilars space.

OMB Clarifies Hiring Freeze for FDA

A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service.

Hopefully,

States Getting into Pricing Issues – Look Out Below!

Seems like every day we see new proposed legislation being introduced into another state’s legislature.  Each one seems to have a somewhat different methodology or focus for controlling and reporting on drug prices.  Let’s think about this.  Everyone wants to strive for lower drug prices.  Remember, in the early 1980’s, the entire nation was focused on reducing health care costs and the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act) came along to address drug prices and associated health care costs while providing additional protections for band name drug products. 

Foreign Inspection Program Feels the Freeze

In the past week, the news media reported on President Trump’s meeting with some leaders of big pharma and among the themes discussed were the lowering of drug prices, cutting regulation, speeding up drug approvals and bringing jobs back to the U.S.  Previous postings have pointed out how the administration’s current freeze on Federal hiring may have the unintended effect of slowing drug approvals (see here).

May Not Be a Rash Decision to Worry About a Rash

The FDA issued a safety warning on Thursday afternoon regarding the potential for rare but serious adverse reactions (including anaphylaxis, hives and severe rash) for a common skin sanitizing agent.  The warning focuses on chlorhexidine gluconate which is available both as a prescription and over-the-counter product for use as a skin sanitizer.  In addition, the product is also available in an oral for use in gum disease products but those products already have the warning.

Let’s See if We Get this Right

Remember the old FDA Monthly Approvals Report that never really provided numbers that matched the approvals that OGD reported in their Activities Report of the Generic Drug Program (Activities Report)?  (see story here). We reported a usual 5-10% discrepancy relative to approvals between the reports.  Well, the FDA Monthly Approval Report was discontinued many months ago,

Who IS Going to Be the New Boss at FDA?

Well, not naming any names- I really won’t come out and say who my pick would be, but, depending on the administration’s pick, this is a pretty crucial decision for the Agency.  Here are some of the attributes I think would be important for the position:

  1. A knowledge of the FDA review and approval process
  2. A strong medical background
  3. A person that believes that science should rule the day
  4. Someone who is above the political fray
  5. A person that has both compassion and common sense
  6. Someone with an understanding of how the drug industry operated

Which of these attributes do I think is most important? 

Certify, Little viii, or Verification Must Now Be in Amendments for Certain Applications

For years, the debate as to when an amendment to an ANDA or a 505(b)(2) application had to include a new patent certification raged on, and, at times, was handled on a case-by-case situation if it was noticed at all. Even when I was at the Agency – when dinosaurs walked the face of the earth- there was disagreement among staff as the when such amendments required new patent certifications or little viii statement. 

USP, BP, EP, JP – Which Can You Cite In Your Application?

FDA published an updated Manual of Policy and Procedure (MaPP), 5310.7 after a 10-year first edition and this one (in my opinion) really clears up one of the age-old questions – can I cite a foreign compendia as the basis for establishing a specification or test method in my application?  The answer is a resounding YES!if the method is as good as or better than the USP/NF provisions in a Monograph or in the General Chapters.

No New Regulations – No New Hires – Will the Administration’s Actions Impact the Drug Approval Process?

Donald Trump signed an Executive Order freezing government hiring, except for the military, national security, or public safety personnel, and issued a memorandum placing a moratorium on any new regulations or Guidance. In addition, it is reported that the memorandum noted that if new regulations have been sent to the Federal Register, but yet unpublished,