Hyman, Phelps & McNamara, P.C. Submits Supplemental Comments to FDA to Highlight FDA Description of RUO Guidance in Par Brief

By Jamie K. Wolszon & Jeffrey N. Gibbs –  

On February 15, 2012, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted supplemental comments to FDA’s June 1, 2011 draft guidance (see our previous post here) that would limit the sale and distribution of Research Use Only (“RUO”) products.  HPM’s supplemental comments highlight FDA’s discussion of the draft guidance in a recent government brief submitted in federal court in a case related to drug off-label information.  The government’s description to the court of the draft guidance is inconsistent with the position in the draft guidance itself that RUO manufacturers should cease sales to a customer if they have knowledge of that customer’s diagnostic use.

On October 14, 2011, Par Pharmaceutical, Inc. (“Par”) sued FDA for allegedly violating the First Amendment by improperly restricting the flow of truthful information (see our previous post here).  The government filed its brief opposing Par on January 11, 2012. 

In its brief, the government states that mere knowledge that an RUO is to be used diagnostically is insufficient to establish a new intended use. 

Looking beyond § 201.128 for proof that FDA equates knowledge that a drug is being prescribed for unapproved uses with intent to create a new intended use, Par quotes selectively from a draft FDA guidance document regarding in vitro diagnostic devices approved for investigational and research uses.  Compl. ¶ 69.  The draft guidance says that “FDA may consider a manufacturer’s knowledge of the purposes for which its customers offer and use its IVD [in vitro diagnostic] product, and the manufacturer’s provision of technical support for those activities, to be evidence that the IVD product is intended to be used for such purposes” (emphasis added).  The emphasized language, which Par omits, makes clear that it is the combination of manufacturer knowledge “and” technical support for the customer’s use, not bare knowledge by itself, that may be taken as evidence of the device’s intended use.

Government’s Brief at 28-29. (Emphases in original.)

HPM previously submitted comments to FDA on the Draft Guidance on August 30, 2011, and supplemental comments on September 22, 2011.