Oct. 31, 2011 — Having already missed the Oct. 1 deadline for issuing guidelines to implement the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act (PPACA), the Department of Health & Human Services (HHS) needs to begin the process of fully implementing this law, according to a group of industry and other organizations that wrote a letter to HHS Secretary Kathleen Sebelius urging HHS to move forward.
Although the Oct. 1 deadline passed without HHS providing any reason for the delay or a proposed new strategy for implementation, the deadline for industry to begin collecting data under the law has not changed. Industry is anxious for HHS to get the ball rolling to establish transparency in the financial relationships between pharmaceutical/medical device companies and health professionals and teaching hospitals under the Sunshine Act.
“Time has run out,” remarked Coalition Executive Director John Kamp. “The effective date of the Sunshine rules must be delayed to enable both government and industry to fully prepare for efficient, effective compliance. These rules are way too important to create an unrealistic, reckless compliance deadline,” he said.
Indeed, “an absence of established procedures could harm the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of those relationships,” the Oct. 25 letter states. Signatories to the letter are: the Advanced Medical Technology Association, the Biotechnology Industry Organization, Community Catalyst, Consumers Union, Medical Imaging & Technology Alliance, Pew Health Group, and the Pharmaceutical Research and Manufacturers of America.
Industry also wants to ensure that it has a chance to weigh in on the guidelines before they are final, pursuant to a requirement in the law to “engage stakeholders and allow public comment on any procedures established related to the submission and public reporting of information under Section 6002 of PPACA,” states the letter.
Although industry may have resisted financial transparency in the past, those days are over, Kamp said. “Now, industry needs to know the rules to ensure compliance as well as the context of the data, so that providers and patients understand the purpose and value of industry cooperation, collaboration and innovation,” he noted.
Many industry members have “already invested significant resources in preparing to comply with the Sunshine provision,” the Oct. 25 letter stated, noting that covered entities must begin collecting information required by the law in a matter of weeks – starting Jan. 1, 2012. “Delays in establishing procedures for the submission and public reporting of the required information [March 31, 2013] will make it increasingly challenging for manufacturers to know whether they are meeting their statutory obligation as they begin to collect data in 2012,” the letter states.
Congress had established a three-month window after the original Oct. 1 date to complete implementation of the Sunshine Act. With industry’s deadline for compiling data only nine weeks away, Kamp stated that “good government and reasonable compliance expectations demand a new implementation schedule.”
Oct. 24, 2011 – After the U.S. Supreme Court struck down speaker- and content-based restrictions in Sorrell v. IMS Health, legal experts, drug manufacturers and other industry interest groups are testing the waters to determine whether that opinion leaves the door open for new challenges to certain FDA regulations, specifically the agency’s ban on most off-label promotion, according to an article in The RPM Report.
Kate Rawson writes in the October issue of the publication that the Sorrell decision could lead the U.S. Court of Appeals for the Second Circuit – the same court that “reversed a lower court decision in Sorrell and deemed Vermont’s data mining restrictions to be a violation of the First Amendment” – to overturn the conviction of Alfred Caronia, a sales representative who was charged with promoting a drug for an off-label indication. In light of the Sorrell decision, the Second Circuit considering Caronia’s appeal asked for briefs regarding the relevance of the Sorrell opinion on this case.
The government dismisses the argument that Sorrell affects “the constitutionality of Caronia’s conviction.” The government also denies that FDA regulations lack the “coherence and clarity” to provide manufacturers with the “guidance they need on off-label promotion.”
The Coalition’s John Kamp is quoted in this comprehensive article covering the current state and future of off-label promotion. Read the full article, “Off Label Changes Coming? Sorrell Ruling Prompts New Legal Challenges,” courtesy of The RPM Report.
Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par’s First Amendment right to provide truthful information to physicians and other healthcare providers about the off-label use of Par’s prescription drug, Megace® ES, which is approved for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS).
In addition to prescribing Megace ES on-label to treat their AIDS patients, physicians frequently prescribe the drug off-label to treat wasting in non-AIDS, cancer, and geriatric patients. FDA regulations call for Par to refrain from speaking about the approved use of Megace ES to physicians who may prescribe the drug for unapproved uses.
According to a statement issued by Par, it hopes to “elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, off-label information about prescription drugs to aid in their provision of quality and informed patient care.”
Coalition for Healthcare Communication Executive Director John Kamp is quoted in an article on the filing in Policy and Medicine, saying, “Par’s challenge goes directly to the heart of FDA’s jurisdiction to censor truthful speech by drug sponsors. After the Supreme Court decision in IMS, someone was bound to bring it. Now, the whole industry will be watching.”
To read the full Policy and Medicine article, go to: http://www.policymed.com/2011/10/phar-pharmaceuticals-vs-fda-calling-for-truthful-speech-vs-fda-approved.html
As always, please feel free to post your thoughts on this important issue below.
Oct. 14, 2011 – The European Commission’s announcement this week that it has adopted a proposal to maintain the EC’s current ban on consumer advertising for prescription drugs may have been expected, but it has industry experts in the United States scratching their heads.
European Commissioner for Health John Dalli offered this rationale for the ban in a statement: “Patients are increasingly interested in learning more about the medicines they take. And more and more patients want to have a say in how they are treated. However, the information they are obtaining today in printed form or on the Internet is very diverse and often not reliable.”
To “protect patients from undue promotion” while also allowing them to benefit from “this knowledge of the manufacturers,” the EC proposals “set out strict rules on the information that companies may provide on prescription-only medicines to the public,” Dalli said, while also making it clear that direct-to-consumer advertising “is – and remains – strictly forbidden.”
With consumers around the globe using the Internet and other media to help them understand and research their medical conditions, the continued EC DTC ad ban seems like a major step in the wrong direction, said John Kamp, Executive Director of the Coalition for Healthcare Communication.
“No wonder the EU is teetering on the edge of bankruptcy,” Kamp said. “EC regulators still think they can help patients by limiting the information provided by drug companies while the snake oil sales pitches from others proliferate. How does that help patients?” he continued. “The U.S. Supreme Court decision in IMS v. Sorrell makes me glad to be an American.”
Under the ban, originally issued in 2008 in response to requests from the European Parliament regarding increased consumer use of the Internet to search for drug information, “only certain information on prescription-only medicines,” such as use instructions, clinical trial data and price, are permissible.
This information also must meet certain quality and evidence-based standards, be unbiased and be verified by regulatory authorities. The updated proposal does allow information on prescription drugs to be disseminated through “limited channels of communication,” such as “officially registered internet websites.”
Opponents of the 2008 ban had asked for the EC to consider the needs of the patient. Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, told the Coalition for Healthcare Communication that patients need to become increasingly engaged in their prescription drug choices, and demand more information, not less.
“Slow and steady does not always win the race. In this case, the race to improve the public health [calls for] more regular and robust patient education via active participation,” Pitts said.
Oct. 11, 2011 – The FDA is seeking to provide more complete compliance and enforcement data to the public and regulated industry, according to a document issued last week by the agency’s Transparency Task Force.
The document, “Draft Proposals for Public Comment to Increase Transparency by Promoting Greater Access to the Agency’s Compliance and Enforcement Data” includes recommendations “focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making,” the agency stated in a press release.
Among the proposals is a recommendation that the FDA “explore ways to better utilize social media, such as Facebook and Twitter, as well as Agency-sponsored webinars and automatic e-mail notifications,” to better communicate with its constituents (Draft Proposal 7).
The task force also calls for the agency to look for ways to better present its compliance and enforcement data graphically and better utilize mobile Web applications to draw more users to its compliance and enforcement Web pages (Draft Proposal 3). The document states that the agency already has implemented this proposal “by developing a centralized webpage where stakeholders can easily access” press releases regarding the filing and resolution of enforcement actions filed by the Department of Justice on the FDA’s behalf.
The FDA also states it has placed “a number of enforcement-related datasets on the Data.gov website.” Further, the agency has launched a redesigned Web page and a phone app to permit the public to search easily for enforcement information.
Other proposals direct the FDA to focus on more timely data disclosure, develop user interfaces, integrate compliance and enforcement data, determine whether additional data compilations or analysis would “increase transparency or better inform the Agency’s own compliance efforts,” and decide if providing appropriate context for the noncompliance and enforcement data that it discloses might avoid misinterpretation or misuse of those data.
Comments on the draft proposals will be accepted until Dec. 2 via http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2009-N-0247. The FDA Commissioner will determine whether to adopt any of the proposals by Jan. 31, 2012.
Oct. 4, 2011 — According to a recent article posted today on the Policy and Medicine Web site, the authors of the Physician Payments Sunshine Act – Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.) — have sent a letter to Centers for Medicare and Medicaid Services Administrator Donald Berwick expressing their “severe disappointment” that proposed regulations to implement the Sunshine Act were not issued by Oct. 1, the deadline imposed by the Affordable Care Act.
To read the full article, which describes the Grassley/Kohl letter, provides details on the Sunshine Act provisions and discusses what the future may hold for these regulations, go to: http://www.policymed.com/2011/10/physician-payment-sunshine-act-cms-misses-deadline-creating-confusion.html
As always, feel free to leave comments on this important issue below.
Oct. 3, 2011 – In his recent Drugwonks blog, Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, suggests that attempts to separate clinicians, medical researchers and drug companies may not be in patients’ best interests. “We must dismantle the battlements and embrace [a] philosophy of ‘symbiosis not schism.’ It’s what’s in the best interest of the patient,” Pitts explains in “Peering Over the Health Cliff.” To read the full article, go to: http://www.drugwonks.com/blog_post/show/7952
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