Nov. 22, 2011 – The Center for Medicine in the Public Interest (CMPI) believes that if politics takes priority over the public health during negotiations for the reauthorization of the Prescription Drug User Fee Act V (PDUFA V), “bad things” will happen. To prevent that outcome, CMPI is leading a panel discussion, entitled “Defining the Future of the FDA: PDUFA V and Beyond,” on Tuesday, Nov. 29.
“When politics trumps public health, patients suffer,” said CMPI President Peter Pitts. “Properly constructed, PDUFA V can help the FDA to aggressively pursue its mission of protecting and advancing healthcare in the United States. Politics has no place. It’s time for all parties concerned to act as colleagues and do the right thing,” according to Pitts.
CMPI’s panel discussion will be held from 12 PM-1:30 PM in Rm. 2168 (Gold Room) of the Rayburn House Office Building on Nov. 29. The panel includes some of the nation’s top experts in PDUFA and FDA reform, as follows:
- Peter Pitts (moderator), Former FDA Associate Commissioner
- Hon. Michael C. Burgess, M.D., Vice Chairman, Subcommittee on Health, U.S. House of Representatives
- Vincent Ventimiglia, Jr., Former Assistant Secretary for Legislation at the U.S. Department of Health & Human Services; Senior Vice President in the Health and Life Sciences Practice at B&D Consulting, a division of Baker & Daniels
- Paul T. Kim, Former Deputy Staff Director for health policy for Sen. Edward M. Kennedy; Partner at Foley Hoag LLP in the Government Strategies Practice
- Michele J. Orza, Former Assistant Director of the Health Care Team at the Government Accountability Office; Principal Policy Analyst at the National Health Policy Forum
- Tim Franson, Former Vice President, Global Regulatory Affairs, Eli Lilly & Co.; President USP Convention; Senior Vice President, Health and Life Sciences Sector, B&D Consulting.
For more information and instructions regarding how to RSVP, please reference the PDUFA Event Invite.
Nov. 22, 2011 – Stating that “a robust dialogue” between pharmaceutical companies and the public “would be seriously chilled” if the U.S. Court of Appeals for the Ninth Circuit upholds the 2009 criminal conviction of former InterMune CEO W. Scott Harkonen for allegedly making false statements about Actimmune in a press release, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently filed an amicus or “friend of the court” brief in support of Harkonen’s appeal.
“The Coalition welcomes PhRMA’s participation in this case,” said Coalition for Healthcare Communication Executive Director John Kamp. “The PhRMA brief demonstrates widespread industry support for forcing federal and state law enforcers to recognize the value of industry communication in managing patient health and the power of the recent Supreme Court decision in Sorrell v. IMS Health to defend against these cases.”
The PhRMA brief asserts: “This case concerns an unprecedented prosecution of a pharmaceutical executive for expressing in a press release his scientific opinion about the development of a drug to treat disease. An affirmance of the decision … would threaten core First Amendment principles by establishing that scientific debate over how to interpret data can constitute a crime.”
PhRMA’s brief calls out the following points:
- The press release in question was not a misstatement of objectively verifiable fact, a trigger for criminal liability;
- The trial court unconstitutionally permitted the jury to find that the press release was false “not because no reasonable scientist could have reached the conclusion drawn, but because some scientists, mainly those of the [Food and Drug Administration (FDA)], disagreed with that conclusion”;
- The trial court’s approach violated the First Amendment because a person “may not be convicted for fraud based upon speech about scientific matters unless the level of scientific consensus is such that no reasonable expert could find the defendant’s statement to be true.”
The amicus brief reiterates the Supreme Court decision in Sorrell, which “confirmed that pharmaceutical manufacturers’ communications with doctors about the safety and efficacy of drugs fall within the First Amendment ambit.” PhRMA then states that “the courts should be particularly leery of a government’s attempt to criminalize speech concerning ‘the effectiveness of [a] particular method of treatment of disease.’”
“Sponsor companies have the best information available on the safe and effective use of their drugs,” according to the Coalition’s Kamp. “Systematically eliminating their participation in discussions with healthcare professionals harms patients. It’s time for government to rationalize these rules in court.”
In addition to the Harkonen appeal, other cases that the Sorrell decision may impact in the near future include:
- U.S. v. Caronia appeal: Alfred Caronia claims that FDA’s limitations on speech regarding off-label uses violated the First Amendment. The U.S. Court of Appeals for the Second Circuit requested additional information following the Supreme Court’s Sorrell decision.
- Par Pharmaceutical Inc. v. FDA: Par seeks to preserve its First Amendment right to provide truthful information to physicians and other healthcare providers about off-label uses. The case, filed with the U.S. Court of Appeals for the District of Columbia Circuit, calls into question the FDA’s authority to censor truthful speech by drug sponsors.
- An appeal by three former Purdue Pharma executives who pled guilty to misbranding charges regarding off-label marketing, is slated to be heard Dec. 6 by the U.S. Court of Appeals for the District of Columbia Circuit. The former Purdue executives are appealing their exclusion from federal health care programs.
“There is no doubt that Sorrell empowered companies and industry advocacy groups to question the government’s authority when it attempts to chip away at the protections afforded speech by the First Amendment,” Kamp said. “We applaud PhRMA for getting involved.”
By Jack E. Angel, Education Foundation Executive Director, Coalition for Healthcare Communication
Nov. 14, 2011 — In response to Opioid prescription drug misuse in this country, the FDA recently released a draft “blueprint” on the basic elements to be included in REMS (Risk Evaluation and Mitigation Strategies) educational programs required of the manufacturers by the FDA.
The guidelines set forth “core messages” intended for use by CME (continuing medical education) providers to develop educational materials for prescribers of long-acting and extended-use opioids. This Blueprint for Prescriber CME is a good foundation for what the FDA wants to accomplish, but raises questions that need to be addressed by the CME community.
In describing how CME providers “will conduct prescriber education” in a Nov. 7 Federal Register notice, the agency stated the following:
“The REMS notification letter expressed FDA’s expectation that the training would be conducted by accredited, independent continuing education providers. FDA later elaborated on its vision for prescriber education stating that we expect the CE training to be provided without cost to the healthcare professionals and that sponsors would offer unrestricted grants to accredited CE providers to develop CE for the appropriate prescriber groups.”
The concern on the part of the CME community is whether the regulated industry’s involvement in the process violates the basic tenets of certified CME. Although the new guidelines likely will generate greater commercial support for certified CME, many in the CME community are fearful of undermining the independence of certified CME providers, a significant industry self-regulation advance over the past decade.
The Coalition for Healthcare Communication strongly supports the provider independence principles. Moreover, it also is dedicated to the thesis that truthful education and industry communication contribute greatly to more effective and efficient healthcare delivery. Industry collaboration is key to advancing patient care through education of doctors and other healthcare professionals.
So, the question here is how do we support these principles while helping to address a pressing national emergency? It seems to make sense for the stakeholders to put their heads together to figure out a way to assist the government by utilizing information, talents, and resources that it may not have. In our view, everyone wins with this effort.
The government is seeking comment on this blueprint and the Coalition intends to weigh in. What do you think? Let us know.
Nov. 8, 2011 — The Association of Medical Media (AMM), a Coalition for Healthcare Communication member organization dedicated to educating and promoting the value of medical publishing and communications, will be holding a meeting next week for AMM members and media agency professionals to discuss the current and future state of digital health communications.
The Nov. 17 meeting, which will be held in New York City, will be moderated by Mark Bard of the Digital Health Coalition. Bard is the co-founder and former CEO of Manhattan Research. Together with his Manhattan Research co-founder Joe Farris, he established the Digital Health Coalition to engage regulatory agencies and the news media in the dialogue about regulation of drug and device companies’ digital marketing efforts.
“The industry, not the FDA, must set the standards and best practices for medical information on the Internet. This project by the Digital Health Coalition promises to advance and improve the medical information available on the Internet,” according to John Kamp, Executive Director of the Coalition for Healthcare Communication. Kamp is a member of the Senior Advisory Board of the Digital Health Coalition and is participating in the development of its programs and projects.
The session, entitled “Insights, Opportunities and Trends from the Future of Digital Health,” will provide an update on efforts underway by the Digital Health Coalition. The session will cover trends in social media adoption and regulation, as well as mobile health. Advertising agency personnel are welcome to attend at no charge.
For more information about the meeting and to register, go to: http://www.ammonline.org/november-2011-event
By John Kamp, Executive Director, Coalition for Healthcare Communication –
Nov. 7, 2011 – Until the research labs and the FDA approval process deliver more medicines, neither patients nor industry can start singing “Happy Days Are Here Again.”
But, the report last week from the FDA Center for Drug Research and Evaluation does demonstrate substantial progress, at least for specialty drugs, orphan drugs and even a few larger-scale oncology medicines.
Indeed, despite rumors to the contrary, medical innovation is not dead. Thanks to continued research investment by industry and a clear commitment by the FDA to approve drugs while effectively managing risk, medicines for cancer and other increasingly difficult conditions are being approved and used to both extend the lives and improve the quality of life of patients.
The FDA’s report card for drug approvals in the past year looks pretty good. Although most of the approvals are for drugs with relatively small markets, each one denotes progress. The agency approved 35 innovative new drugs – the second-highest number of new drugs approved in a given year during this decade. Further, 24 of the 35 new drug approvals occurred in the United States “before any other country in the world and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines,” according to an FDA press release touting the results.
And, while industry and patient groups may not be ready for a ticker-tape parade, the FDA report credited the following for the increase in approved new drugs:
- Expedited approval authorities;
- Flexibility in clinical trial requirements; and
- Resources collected under the Prescription Drug User Fee Act.
“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Commissioner of Food and Drugs Margaret Hamburg, M.D. “We are committed to working with industry to promote the science and the innovation it takes to produce breakthrough treatments,” she stated.
Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President for Scientific and Regulatory Affairs Dr. David E. Wheadon expressed a similar sentiment, issuing the following statement regarding the FDA’s report: “The FDA’s report on new drug approvals – finding that 35 new molecular entities received FDA approval in fiscal year 2011 – demonstrates the shared commitment of biopharmaceutical research companies and the agency to medical progress and patient care.
“By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs. Of course, the tremendous value of these advances – and FDA’s review and approval of them – underscores the importance of expedient approval of a clean Prescription Drug User Fee Act (PDUFA), which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function.”
PhRMA’s Dr. Wheadon put his finger on it. Congress can pass a clean PDUFA bill that enables efficient scientific reviews using user fees. Or it can make it an “ugly Christmas tree,” as they call it on Capitol Hill, loading it up with so many ornaments that the whole thing falls over from the dead weight. Several nasty ornaments are being readied by “consumer groups,” including additional marketing and “conflict of interest” regulations. Members of Congress must reject these to enable both the innovation and communication that brings drugs to patients.
Most importantly, for patient’s sake, industry/government collaborations must be fostered. It is confluence of interest that makes medical innovation progress. Let’s keep up the momentum.
Nov. 1, 2011 – In response to a recent letter from Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.), co-sponsors of the Physician Payments Sunshine Act, regarding a missed Oct. 1 deadline for issuing implementation guidelines, Centers for Medicare & Medicaid Services (CMS) Administrator Donald Berwick pointed to an Executive Order issued by President Obama as the reason for the delay.
This directive calls on all federal agencies to take steps to reduce regulatory burden. Although Berwick states that he believes “we can implement the statutory goals [of the Sunshine Act] … while minimizing burden on the regulated parties,” and that CMS is “working hard to ensure we meet these goals,” Berwick does not respond directly to the concerns raised by Grassley and Kohl in his Oct. 28 response letter. He does indicate that CMS staff members are “engaged in stakeholder outreach regarding the implementation of the provision,” but does not offer any new timeframe for that implementation.
In their Oct. 3 letter to Berwick, the senators expressed their “severe disappointment” that proposed regulations to implement the Sunshine Act were not issued by the Oct. 1 deadline imposed by the Affordable Care Act. An Oct. 25 letter from several industry organizations to HHS Secretary Kathleen Sebelius also called on the federal government to move forward with issuing regulations now that the effective date for industry is a mere nine weeks away.
“CMS Administrator Berwick is absolutely right to focus on the need to balance the value and the burden of Sunshine Act compliance,” said John Kamp, executive director of the Coalition for Healthcare Communication. “The next best step would be to reset the start date so that everyone has an opportunity to digest and comply with the rules.”
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