505(q) Petitions Still Eating Up Valuable Agency Resources

The FDA has released its required annual report on 505(q) petitions.  Such petitions are characterized by their intent to ask the FDA to either delay approval of an abbreviated new drug application, a 505(b)(2) NDA, or a biosimilar under 351(k) of the Act.  Our good friend Kurt Karst, Director at Hyman, Phelps & McNamara, has outlined the history of 505(q) petitions and the issues addressed in the report here:
He did such a good job that we are not going to delve further into the numbers. 

Let the Sun Shine on OTC Sun Screen Products

The FDA has revised and finalized its previously issued (2011) Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance for Industry.  FDA notes that “this guidance applies to OTC sunscreen products marketed without approved applications and describes FDA’s approach to enforcement for these products until a final OTC sunscreen monograph becomes effective.”  The Agency also indicates that several rulemaking activities will also be initiated that will address these products.

OGD Updates March 2018 Statistics

The Office of Generic Drugs (OGD) filled in the remaining data boxes in the  March Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) and there are some very interesting numbers to point out.

Of the 9 refuse-to-receive (RTR) actions OGD issued last month, 6 were for GDUFA II priority applications,

PDUFA VI Fee Process Explained in Final Guidance

By now we all know that the fee structure for NDAs and BLAs has changed with the passage of PDUFA VI.  We know that now there are only application fees and “program fees” (program fees are the same as previously assessed product fees).  The FDA issued a final guidance entitled “Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017” today which explains the fundamental issues associated with the new fee structure such as

  • how fees are to be assessed
  • when fees are assessed and due
  • what waiver provisions are still in place and which are no longer available
  • definitions of prescriptions drug products
  • effect of failure to pay fees
  • payment information and procedures
  • fee waiver provisions,

So How is that Prescription Drug Imported On-line from Canada?

With all the discussions of reducing prescription costs, the importation of drugs from Canada almost always appears in the debate.  While there are many reputable Canadian on-line and brick and mortar pharmacies from which to import prescription drug products, I have never thought that it was a good idea.  ABC News (here) seem to validate my opposition.

FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions

We do not often blog on the issue of dietary supplements but in this case the FDA is making a serious point by issuing a guidance entitled “Highly Concentrated Caffeine in Dietary Supplements” which can be found here. This comes after several deaths from consumers taking lethal doses of pure or highly concentrated powers or liquid caffeine containing products.

New Grant Applications Sought for Topical Products

The FDA has struggled with the best methods to determine the bioequivalence of topical dermatological drug products for years. For example, FDA considered numerous methods including transepidermal water loss (TEWL), skin stripping, and others to demonstrate the bioequivalence of retinoid acne products.  None were found acceptable and the Agency ultimately relied on bioequivalence studies with clinical endpoints to approved generic versions of these cream,

Outsourcing Facilities Make the News Again

On April 12, 2018 FDA posted yet another recall announcement by a registered outsourcing facility (here).  Ever since the New England Compounding Center’s problems associated with the meningitis outbreak, FDA has been diligently inspecting compounders registered as outsourcing facilities with the Agency.  Today’s announcement highlights a continued sterility assurance concern by the FDA.

A New OGD/OPQ Review Assessment Coming to an Application Near You – But Not for a While!

Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research (CDER) at the AAM Annual Meeting today, gave some hope to generic applicants regarding the way agency assessments will be conducted in the not too distant future.  The goal is to improve the efficiency and effectiveness of the review process.  Why is this necessary?  Dr.

President’s Budget Has a Hidden Change to Hatch-Waxman — Watch Out.

There is a proposed change to 180-day exclusivity which is awarded to the first -to-file (FTF) applicant with a paragraph IV certification.  The proposal would trigger the 180-day exclusivity period if a subsequent applicant obtains tentative approval prior to the FTF applicant gaining final approval.  While this on its face may in some instances appear to permit a generic applicant to enter the market faster,