26 New Bio Guidance and 17 Guidance Revisions since March 27, 2018

Sometime today, according to a pre-publication in the Federal Register, the FDA will post twenty-six new bioequivalence guidance documents and announce the revision of seventeen more.  Since February 2018, the FDA has issued sixty-one new guidances and revised forty.

The OGD has indeed been busy but while the industry loves to see the new guidances,

FAR from Reality – Q&A Document Provides Answers to Age Old Questions

In my 44 years in the industry, I don’t think any issue has raised as many questions, caused companies to scratch their heads or raised the level of angst more than the issue of the dreaded Field Alert Report (FAR).  Well now – and finally – the FDA has issued a Q&A document that answers many of those head- scratching questions.

FDA Updates Patent Listing Disputes

When an NDA holder lists a patent in the Orange Book (OB), it sometimes appears that the patent listing use claim, or other information is challenged by prospective ANDA applicants.  FDA has updated its Listing of Patent Disputes (here) through July 13, 2018.  This is the first time that we have seen this list (maybe we were asleep at the switch),

More OTC Products Coming to a Shelf Near You?

FDA approves two types of drug products –Prescription (Rx), and Over-The-Counter (OTC).  Well, they also approve other types, i.e., Biologics etc., but for the purposes of this Blog post, it is the Rx and OTC that are applicable.

Prescription drugs require the intervention of a health care provider, and are typically for products where the patient cannot self-diagnose the condition for which the product is intended. 

Valsartan API impurity Leads to Recall of Some Products

Very seldom do we see a notice of recall that relates to a change in the manufacture or processing of the Active Pharmaceutical Ingredient (API), but that is what appears to have happened in this instance.  The FDA announcement states:

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan,

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,