Recent wins for pharmaceutical marketing research in Maine and DC leave only West Virginia and Vermont as the jurisdictions currently restricting or prohibiting research with physicians and healthcare professionals. Although hope remains that West Virginia might come around, the door has closed on pharmaceutical marketing research in Vermont for the foreseeable future. These changes stemmed fundamentally from the enactment of the federal Physician Payments Sunshine Act as part of the 2010 Patient Protection and Affordable Care Act (PPACA) -- a law that, thanks to lobbying by MRA, excludes marketing research incentives from its reporting requirements for payments to physicians from pharmaceutical and medical device manufacturers.
Existing law in Maine (22 M.R.S.A. §2698-A) required that pharmaceutical drug manufacturers annually report on their marketing expenses to Maine residents, specifically to Maine physicians. Although the law made no reference to survey research, the implementing regulations did:
(2.04-2)(A) “All expenses directly associated with… Payments made directly or indirectly to such persons or entities in connection with market research surveys or other activities undertaken in support of developing advertising and/or marketing strategies.”
MRA had advocated against the regulations and shared our endorsement for H.P. 530 with the bill’s sponsor and the members of the Joint Health and Human Services Committee prior to a crucial hearing in May.
The repeal is effective September 28, 2011. How permanent will this repeal really be? According to Maine Rep. Sharon Anglin Treat (D-79), Executive Director of the National Legislative Association on Prescription Drug Prices (NLARx), “In terms of next steps, it would be foolish to try to reverse these repeals with the current Legislature and governor. If Maine people want a different result (and understand what has happened) then they will elect different people the next time around.”
The District of Columbia
Title III of the AccessRx Act (implemented in Chapter 18, Title 22) set annual reporting requirements for the marketing costs of manufacturers and labelers of prescription drugs. Although the law made no mention of marketing research, the regulations specifically mentioned the reporting of direct or indirect payments for participation in marketing research. This led most pharmaceutical manufacturers and labelers to avoid marketing research with DC physicians.
MRA had campaigned to exclude marketing research incentives from the DC regulations for several years. On August 4, 2011, thanks to the dogged efforts of MRA volunteer Rick Seale (Shugoll Research), MRA’s lobbying campaign since 2007, and a contract lobbyist hired by CASRO, CASRO was able to share the news that the DC Board of Pharmacy had approved an exclusion for payments to health care providers for participation in marketing research, if: “(i) the market research is conducted by an independent survey research organization; (ii) the pharmaceutical client does not know the identity of the practitioners who participate in the research; and (iii) the payments are determined and made directly by the survey research organization.”
Because the reporting requirements in DC are on an annual basis, this new exclusion for marketing research payments is effective immediately.
Going in the opposite policy direction, the state of Vermont has now explicitly prohibited marketing research incentives for physicians who participate in pharmaceutical research. Existing law was unclear on how it impacted marketing research incentives. Although the Attorney General’s office hinted that it did not think the law applied to marketing research, pharmaceutical manufacturers already avoided all marketing research with Vermont health care providers.
Unfortunately, as MRA predicted, Vermont Governor Peter Shumlin (D) signed S.B. 108 into law as Public Act 51 on May 26. The new law explicitly outlaws incentives for health care providers participating in pharmaceutical marketing research, stating: “no manufacturer or other entity on behalf of a manufacturer shall provide any fee, payment, subsidy, or other economic benefit to a health care provider in connection with the provider's participation in research.”
As explained above, this does not change the effective status quo -- no pharmaceutical marketing research with Vermont health care providers was happening anyhow. The anti-pharmaceutical activists in the Vermont House who spiked our efforts to exclude marketing research will likely ensure that this law does not get overturned or fixed any time soon.
The Battle Continues
With the legal ambiguity in Vermont resolved to the detriment of marketing research, this leaves Vermont and West Virginia as the only states that still restrict pharmaceutical marketing research incentives for physicians. While the federal Sunshine Act does not come into effect in 2013 (assuming it is not overturned before then), it has already discouraged most states from pursuing similar reporting payment disclosure laws (which could end up pre-empted by the Act) and directly led to the repeal of Maine’s superfluous law.
We've had some other victories this year, such as with New York S.B. 2855, which MRA helped to defeat in February. We also testified in favor of an amendment to Maryland H.B. 818 to exclude marketing research -- while the amendment was successful, the bill was eventually withdrawn. MRA also closely monitored the attempt by the Massachusetts House to repeal that state's physician gift restrictions -- restrictions which, thanks to MRA's lobbying campaign in 2009, explicitly exclude marketing research incentives -- which was ultimately rejected in a compromise with the Senate.
MRA continues to campaign regardless against other state legislation that could impede pharmaceutical marketing research, including: H.B. 45 in Alaska; A.B. 1636, S.B. 212 and A.B. 5978 in New York; S.B. 79 in Ohio; and H.B. 1544 and S.B. 515 in Massachusetts.