Congressional Interest in FDA Remains High, Even After the Enactment of FDASIA

By Kurt R. Karst –      

Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House of Representatives.  With an election on the horizon and several other non-FDA-related issues to handle, it seems highly unlikely that Congress will be poised to tackle the FDA bills this year; however, they may provide some insight into some of the issues that will be debated in the 113th Congress come 2013.

H.R. 6272 – The Trial and Experimental Studies Transparency (“TEST”) Act of 2012

According to a press release from the primary sponsor of the bill, Rep. Ed Markey (D-MA), the TEST Act would close certain “clinical trial loopholes and bring certainty and transparency to life-saving research studies.”  Among other things, the bill would amend the definitions of “applicable device clinical trial” and “applicable drug clinical trial” at PHS Act § 402(j)(1)(A) to require that “all interventional biomedical studies on humans” be registered at ClinicalTrials.gov “before the first participant is enrolled in the trial.”  Although current draft guidance on clinical study registration explains that certain studies conducted outside of the United States do not need to be reported on Clinicaltrials.gov, the TEST Act specifically applies to “any interventional study of a [drug or device] conducted outside of the United States the results of which are submitted to the Secretary in support of” a marketing application, including a PMA and 510(k) notification for devices, and an IND, NDA, BLA, or ANDA for drugs and biologics.  (Applications for biosimilars under PHS Act § 351(k) are not specifically mentioned in the bill, but the broad reference to PHS Act § 351 presumably includes them.)  An “interventional study” is defined in the bill to mean “a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical or health-related outcomes.”  Support for the TEST Act has already appeared in the pages of The New England Journal of Medicine (see here).

H.R. 6288 – The Patient Choice Act of 2012

According to Rep. Brian Bilbray (R-CA), who introduced H.R. 6288 (see here), the bill is intended to “speed up the approval process of drugs used in therapies and treatments of patients fighting life threatening diseases.”  It would do so by establishing a “provisional approval” system for a product designated by FDA as a “fast track” product under FDC Act § 506.  (FDASIA made several amendment to FDC Act § 506 – see here.) In order for FDA to grant a request for provisional approval, the Agency would have to determine that a product is “adequately safe.”  This term is defined in the bill to mean that “for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug, as determined in one or more safety studies or through other data that the Secretary determines are sufficient, is unlikely to be greater than the combined direct and secondary risks of death or morbidity, as established in the literature or historical data” of the target disease, among other things.  The bill also contains provisions on the requirements for products granted provisional approval, and on the timing of the start of marketing exclusivity.

H.R. 6342 – The Compassionate Freedom of Choice Act of 2012

The Compassionate Freedom of Choice Act of 2012 was introduced by Rep. Ron Paul (R-TX) (see here) and is intended to allow the importation, distribution, and sale of investigational drugs and devices by terminally ill patients if their physicians certify: “(i) such patients have no other treatment options; and (ii) the patient executes written, informed consent that they are aware of any potential risks from the drug, device, or treatment.”  According to one advocacy group, H.R. 6342 “would substantially limit FDA’s ability to second-guess treating physicians’ decisions concerning the standard and methods of care available to terminally ill patients.” 

S. 3506 – The Ethical Pathway Act of 2012

S. 3506 was introduced by Sen. Bernie Sanders (I-VT) and is intended to “eliminate requirements to undertake duplicative clinical testing of new pharmaceutical drugs, vaccines, biological products or medical devices, when such duplication is inconsistent with relevant ethical norms” (e.g., the Declaration of Helsinki).  To do this, the bill, if enacted, would require FDA to establish a mechanism by which an applicant may request a cost-sharing arrangement with the owner of existing regulatory test data.  The bill is in line with other legislation introduced by Sen. Sanders to create a prize-based system for new drugs, instead of one with patent and non-patent exclusivity incentives (see here and here).