On July 11, 2014, the FDA issued a new Draft Guidance (the Guidance) that will require drug companies to submit information on most drug samples that they distribute in the United States. The new Guidance is entitled “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act.”
This new Guidance updates a previous 2012 Draft Guidance dealing with a provision of the Affordable Care Act (Obamacare) that requires the submission of certain drug sample information to the FDA not later than April 1 of each year. Under the Act, the submission of such information was to have begun on April 1, 2012 but, in the 2012 Guidance, the FDA had said that — as an exercise of its enforcement discretion — it would not require companies to submit anything until “further notice.” That “further notice” has now occurred and the FDA is saying that it will now require the submission of data for calendar year 2014 by April 1, 2015. So if a drug company is distributing samples of drug products as defined in the Act, it is important to have in place procedures to capture the information on distribution data so that a full 2014 report can be made.
Set forth below is a brief summary in bullet point format of what is necessary under the new Guidance.
- Applicable Drugs: The Guidance says that applicable drugs are prescription drugs “for which payment is available under title XVIII of the Social Security Act (SSA) or a State plan under title XIX or XXI of the SSA (or a waiver of such a plan).” In English, what this means is that the applicable drugs are those prescription drugs subject to Medicare and Medicaid.
- Drug Sample: This is defined in the same way as it is under the FDA’s existing Prescription Drug Marketing Act (PDMA) regulations as a “unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.” See 21 CFR 203.3(i).
- Who Must Submit Drug Sample Information? Both the manufacturer and the Authorized Distributor of Record (ADR) are required under the Act to submit drug sample information. However, the FDA says in the Guidance that, where a manufacturer and an ADR both have records regarding the same drug sample request or distribution, only one of the two entities should submit the drug sample information.
- How Should Drug Sample Information Be Reported? FDA “strongly encourages use of the Agency’s existing Electronic Submissions Gateway.”
- What Information Should be Submitted? The Act requires that the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by the name, address, professional designation, signature of the practitioner making the request, and signature of the practitioner or the practitioner’s designee receiving the distributed drug samples. In general, this is the information already required to be collected (but not to be submitted) under the PDMA. The FDA says, however, that the actual, individual signatures need not be submitted and the Electronic Submissions Gateway has checkboxes to indicate whether the signatures are on file with the manufacturer or the ADR.
- Period Covered By Each Report: Information is required for each calendar year previous to the April 1 date for reporting. Thus, for the first required report, information on calendar year 2014 will need to be reported by April 1, 2015.