Oct. 8, 2013 – Although the Food and Drug Administration (FDA) has moved aggressively to approve new drugs recently, the FDA’s marketing policy priorities and its interpretation of the First Amendment do not always mesh with industry’s priorities, according to speakers at the Coalition for Healthcare Communication members meeting held recently in Washington, D.C.

“Attendees of the recent Coalition for Healthcare Communication D.C. meeting were given a deep dive into FDA and HHS policy issues,” explained John Kamp. “While there is much good news on the drug approval front, little progress has been made to bring FDA marketing policy into the 21st Century or to align it with traditional free speech principles,” he said.

Wayne L. Pines, APCO Worldwide, pointed out at the Sept. 24 meeting that the FDA has been “leaning over backwards to work with industry and the patient community” and has used well the Risk Evaluation and Mitigation Strategy (REMS) provision, which “gives FDA a mechanism for approving drugs with provisos and gives the agency a way to get drugs on the market with risk management.”

However, several of the major issues being addressed by the healthcare marketing industry – the possible elimination of an advertising tax deduction, the Physician Payments Sunshine Act, privacy proposals to limit communication with professionals/patients, and enforcement and emerging policies – “are not on the radar at FDA,” Pines explained. The Coalition, he noted, “helps to keep these issues on the radar screen. I urge all of us to continue to push for these issues.”

Just days before the federal government shutdown by Congress, Pines  made it clear that the budget concerns the agency is facing even under sequestration have affected the Center for Drug Evaluation and Research (CDER). For example, under sequestration, in the fiscal year that ended Sept. 30, $85 million in user fees that were supposed to be dedicated to application reviews ended up in Treasury Department, not FDA, accounts. Without these funds, “the FDA is hurting financially,” Pines said. “CDER staff members are not attending meetings and are not conducting some inspections, but they are working overtime” to ensure that “mandates without money” are being met.

To illustrate his points, Pines shared FDA slides listing CDER’s top priorities at the end of the fiscal year:

• Quality-related drug safety
• Drug shortages
• Implement FDA Safety and Innovation Act
• Improve and streamline drug development
• Globalization efforts

“As you can see, none of the issues [the Coalition is] focused on are on that list, but it’s important to remember that you can develop all the drugs you want, but if you can’t sell them, they are not going anyplace.” Pines’ comments underscored a sentiment raised at a Sept. 23 dinner session of the Coalition meeting by speaker Mike McCaughan, Senior Editor, The RPM Report. “There is this dilemma where everyone wants the industry to develop new drugs, but apparently selling them is wrong,” McCaughan said, adding that “marketing should be part of the value proposition, not a crime.”

CDER’s Office of Prescription Drug Promotion has its own list of top priorities, which include the following:

• Policy and guidance development
• Labeling reviews
• Core launch reviews and TV ad reviews
• Enforcement
• Training and communications

One of the most-awaited guidance documents – covering social media – is due out by July, according to Pines. However, he advised that “if you are looking for a guidance that is anything other than the status quo, look elsewhere.” McCaughan also said that the FDA’s guidance in this area “should be useful, but not surprising.”

Alan Bennett, Partner, Ropes & Gray, told Coalition members that the communication of scientific information is an issue “that takes a lot of work from the outside to keep moving forward.” He discussed three major cases that deal with industry’s First Amendment rights to share information about their products. These cases and the resulting decisions are as follows:

• Sorrell v. IMS Health (2011) – Restrictions on pharmaceutical company speech are subject to “heightened scrutiny.” Cannot single out a special class, e.g., manufacturers, and restrict their speech when everyone else is fine to say the same thing.
• FCC v. Fox Television Stations (2012) (Fox II) – Regulatory schemes are unconstitutional if too vague.
• U.S. v. Caronia (2012) – The Food, Drug & Cosmetic Act does not criminalize “pure” speech, even if it is off label.

“We all believe that the FDA has to pull in its definitions based on the new case law and the subsequent comments,” Bennett said. “But where all of this goes remains to be seen. The FDA has begun to articulate why Caronia does not apply to them. I would not be surprised if a company or another group sues the FDA over this, and it’s hard to see how the scheme survives as is, because it doesn’t comport with case law,” he continued.

Bennett also explained that three key groups have been active in forwarding the industry’s position in these types of cases: the Medical Information Working Group (MIWG) (a group of 13 medical product manufacturers that has submitted multiple citizen petitions and comments to the FDA regarding scientific exchange and communication with payers (see related article, http://www.cohealthcom.org/2013/09/16/miwg-asks-fda-to-clarify-position-regarding-manufacturer-dissemination-of-new-use-information/)); the Pharmaceutical Research and Manufacturers of America (PhRMA) (provided comments to the scientific exchange docket asserting that truthful and non-misleading communications should be considered free speech; provided comments on FDA’s unsolicited requests draft guidance and other matters); and the Washington Legal Foundation (WLF) (provided comments on unsolicited requests draft guidance and wrote a letter to the Centers for Medicare & Medicaid Services regarding the reporting requirement for medical textbooks under the Sunshine Act).

Based on these activities and the new legal precedent, the agency should be getting the messages that it needs “to put a First Amendment filter on its responses,” Bennett said. “It can’t be that everything that a company says is labeling.”

“Our clients and industry have a First Amendment right to tell the truth about their products,” Kamp said, adding that “Communication is just as important as development. We need magic in the lab, but without communication, products cannot reach their full potential.”