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Dissecting ACA's Section 6004: Tipping the Balance on Sampling Controls?


Pharmaceutical Executive

With the Affordable Care Act [ACA] officially settling into the US’ political landscape, a pressing – but little noticed – issue is the provisions for increased compliance on industry promotion practices.

With the Affordable Care Act [ACA] officially settling into the US’ political landscape, a pressing – but little noticed – issue is the provisions for increased compliance on industry promotion practices.  Of specific concern is Section 6004 of the ACA, which demands more rigorous reporting on the distribution of free samples to physicians from pharmaceutical manufacturers. This particular piece of the legislation replaces parts of the Prescription Drug Marketing Act (PDMA) of 1987 and will begin to be enforced, most likely by early 2013.

Section 6004 now mandates that annual reports on distribution of samples be electronically submitted to the FDA, in contrast to PDMA provisions that left it to the discretion of regulators to request such information.  As noted on the FDA web site:

The Affordable Care Act explicitly states that manufacturers and authorized distributors must submit the following information concerning drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity and quantity of drug samples distributed; (3) the name, address, professional designation, and signature of any person who makes or signs for the request, and (4) any other category of information determined appropriate by the Secretary.

In addition to these requirements, the reports are to be sent to the FDA in XML (Extensible Markup Language) format. Howard Shatz, SPL and ACA 6004 Project Manager at Data Conversion Laboratory, told Pharm Exec that this puts additional obligations on manufacturers who contract their sample distribution to other companies, as “some drug makers will have to check with multiple companies in order to consolidate all of the information required under the law.”

Shatz also points out that this data will be analyzed and speculates “that it could be an easy way of identifying doctors who are abusing the system.”  Clearly, the practice of providing free samples has come under increased scrutiny.  The European Federation of Pharmaceutical Industries and Associations [EFPIA],  established sample distribution caps on members in 2010 as a result of ethical concerns by patient groups and governments, including the assertion that an unlimited “sampling culture” directs physicians away from prescribing more appropriate and affordable medicines. The intent behind the new US reform language is unclear at this point, but with this European precedent and a regulatory climate that is more skeptical of industry marketing claims, the prospect of formal limits on sampling in the US is now on the radar screen.

Nevertheless, opinion remains divided on whether these specific requirements will lead to a broader crackdown on sampling.  Many observers say that bureaucratic realities are such that the provision of advance notice means the data will be applied, rather than just warehoused.  However, there is another aspect to the story:  Section 6004 could render obsolete the push toward tougher state regulations intended to supplement PDMA’s lax directives.  Federal oversight might save companies the headache of accounting for myriad discrepancies in compliance, on a state to state basis.

What is clear is the implications will start to narrow as implementation of Section 6004  moves forward and the effects of the overhaul are assessed in real time by providers, regulators and politicians.   Like it or not, a tipping point in the debate on drug sampling is at hand.

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