July 30, 2012 – A report released last week by the Accreditation Council for Continuing Medical Education (ACCME) shows that the pharmaceutical industry’s funding of CME programs continued to decline in 2011. This trend is likely to continue if regulations to implement the “Sunshine” provisions of the Affordable Care Act proceed as proposed, and could
put an increasing number of patients at risk.
The 2011 ACCME Annual Report Data show that industry support for CME dropped by 11.4 percent, which equates to almost $94 million less spent on CME in 2011 than in 2010. This decline marks an ongoing shift away from industry as the primary supporters of CME activities. In 2007, industry funding represented 46 percent of total funding, but in 2011, industry funded only 32 percent of CME activities.
“The decline in commercial support for medical education demonstrates the folly of over-regulation. While the covered patient population continues to expand and the effective use of medicines is key to efficient and appropriate delivery of care, public policy makers should be developing rules and policies that encourage, not discourage, commercial support for doctor education,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “Transparency is a laudable goal, knee jerk journalism and regulatory over reaction have moved us in the wrong direction.”
Although total income from CME was down 1.1 percent in 2011, income from advertising/exhibits at CME events and “other income,” which included registration fees and funds that came from a provider organization, did help the balance sheet. For publisher/medical education companies, income from CME activities was up 2.4 percent in 2011.
Non-physician attendance in CME events increased by 1 percent, while physician attendance decreased by .05 percent. Overall, publishing/education companies drew the most physician participants, with medical schools and hospitals/health care delivery systems rounding out the top three, according to the report. ACCME notes that its data for 2011 excludes in-kind support for CME and includes state and regional CME statistics.
This downward trend in industry CME spending is unlikely to be reversed by additional burdens imposed by Sunshine provision proposed regulations, the specter of which already may be dissuading health care providers from participating in
CME. Further, if the proposed regulations – which call for CME providers to report the value of education provided for each certified CME program attendee and would mandate that industry value and report each company-sponsored education and research activity – are published as proposed, they could further suppress both CME funding and participation.
“Regardless, I hope the final rules from HHS on the Sunshine Act will be much more sensible than the draft proposals. The industry, including PhRMA, BIO, AAFP, AMA, the Coalition and others have given them a much more sensible road map to effective but more sensible regulation,” Kamp continued. “Meanwhile, let’s take this week’s decision by Massachusetts regulators to kill the ban on drug coupons as a step in the right direction, and applaud similar steps.”
July 23, 2012 –Michael Sauers, team leader (DTC1) at the FDA’s Office of Prescription Drug Promotion (OPDP), held a workshop at the DIA 2012 Annual Meeting that walked attendees through actual examples of where promotional materials for pharmaceutical products fell short of meeting FDA requirements.
During this interactive DIA workshop, “Prescription Drug Marketing Regulatory Primer,” held June 27 in Philadelphia, Sauers provided some basic tenets of prescription drug promotion regulation and then led the audience through a sampling of promotional pieces that the agency found to have violated the regulations.
For example, in describing omission of risk information – a violation commonly cited in OPDP Warning Letters and Untitled Letters – Sauers showed DIA session attendees a promotional flyer for ISTA Pharmaceuticals’ BROMDAY, which was cited in a July 13, 2011, Warning Letter. Although the flyer making claims regarding the use of Bromday in cataract surgery discloses the most common adverse reactions associated with that use, it does not reveal any of the warnings and precautions for the drug.
Promotional materials that make product claims must also provide risk information, according to Sauers, who noted that this risk information should include contraindications, warnings, precautions and pertinent adverse events. Further,
even though the Bromday flyer included the statement, “Please see full prescribing information on reverse,” that reference does not fulfill regulatory requirements, Sauers explained.
In discussing problems with the presentation of risk information, he presented a stall cling for GELNIQUE – cited in a Nov. 30, 2010, Untitled Letter to Watson Pharmaceuticals Inc. – to demonstrate that formatting factors, including the shape, size and general layout of presentations in a piece, are important in achieving adequate risk presentation. The Untitled Letter cited the company for relegating the risk information “to the bottom of the piece and written in white text on a purple background in an extremely small font size and in single-spaced paragraph format, making this information very difficult to read.” In describing how risk information should be adequately conveyed, Sauers also indicated that framing and sequence are important.
Sauers made it clear in his presentation that oral statements not made in response to a request for such information from a physician can be problematic if they discuss unapproved uses. For example, he cited oral statements made by a physician on behalf of Merck & Co. Inc. regarding the company’s SAPHRIS at a lunch presentation. Saphris is approved for schizophrenia and bipolar disorder, but the speaker stated that he prescribes the drug as an adjunctive treatment for major depressive disorder (MDD) and that it works just as well.
Promotional materials should not suggest that a drug is safe and effective for conditions or patient populations that it is not approved to treat, according to Sauers, nor should they suggest that a drug treats outcomes or consequences of a disease if the drug has not demonstrated such an effect on those outcomes or consequences. He added that claims of superiority generally must be supported by adequate and well-controlled head-to-head comparative studies.
Further, claims about efficacy and safety in promotional materials must be consistent with the PI and be supported by substantial evidence derived from adequate and well-controlled studies, Sauers asserted. To illustrate the substantial evidence requirement, Sauers showed attendees a Noven Pharmaceuticals Inc. flash card for PEXEVA.
This marketing piece, cited in a May 24, 2011, Untitled Letter, misleadingly implies that Pexeva is effective in treating patients with co-morbid MDD and generalized anxiety disorder (GAD), when this has not been demonstrated by substantial evidence or substantial clinical experience, the Untitled Letter states: “While Pexeva is indicated to treat MDD and GAD individually, no clinical studies demonstrated efficacy
of Pexeva in treating patients experiencing these two conditions concurrently.”
Overstatement of efficacy – often conveyed through testimonials or imagery – also is a violation that is commonly cited by OPDP. Sauers’ presentation made it clear that patient testimonials and individual case studies may be an accurate reflection of one patient’s experience, but that alone does not constitute substantial evidence.
July 16, 2012 – The FDA’s Office of Prescription Drug Promotion (OPDP) is on pace to deliver the same number of enforcement letters it sent out in 2011, having issued 15 Warning or Untitled Letters to date in 2012. OPDP had issued 17 such letters by this point in 2011.
The seven enforcement letters sent out by OPDP since May 1 were issued for alleged violations relating to a television ad, a branded story, a journal ad, a Web page, a patient brochure and two video segments. OPDP discovered problems with these promotional materials as a result of routine surveillance and monitoring (1), review of materials under Form FDA-2253 (5) and via a complaint received under the agency’s “Bad Ad” program (1).
In a May 25 Warning Letter, OPDP charges that a Pfizer Inc. TV ad for EPIPEN and EPIPEN JR. is false and misleading because it overstates the efficacy of the products. Specifically, the agency took issue with the “overwhelming impression” created by the ad that the EpiPen alone could provide assurance that a child with life-threatening allergic reactions does not need to worry or take precautionary measures to avoid exposure to allergens, according to OPDP. “This violation is particularly alarming from a public health perspective because the misleading presentation of the use of EpiPen may result in serious consequences, including death,” the Warning Letter states.
An Untitled Letter sent to Vertex Pharmaceuticals Inc. on May 25 found fault with a branded story that the company submitted to OPDP for INCIVEK Film Coated Tablets. The letter states that although claims made in the branded story may be an accurate reflection of the story subject’s experience with hepatitis C and treatment with Incivek, it misleadingly implies that most or all similar patients will achieve the same results. “One patient’s treatment response does not constitute substantial evidence,” OPDP states in the letter, which also cited Vertex for omission of material fact and minimization of risk information.
OPDP objected to a journal ad for Watson Pharmaceuticals Inc.’s NULECIT due to unsubstantiated claims, according to a June 7 Untitled Letter. OPDP alleges that the journal ad claims there is a reduced need for erythropoiesis-stimulating agents (ESAs) with Nulecit use and that there are significant cost savings when the drug is added to ESA therapy.
As part of its routine monitoring and surveillance, OPDP reviewed an “efficacy” Web page for KEPIVANCE and found it to be false or misleading because “it omits and minimizes important risk information and makes misleading efficacy claims.” The June 7 Untitled Letter, sent to Quintiles Inc. as the U.S. agent for Swedish Orphan Biovitrum AB, states that although the Web page links to the Prescribing Information and the Kepivance Safety and Tolerability sections of the Web site (which includes the drug’s risk information), “these links are not sufficient to mitigate the misleading impression created by the omission.” OPDP also alleges that the Kepivance Web page included misleading efficacy claims and that the promotional Web pages were not submitted to OPDP using Form FDA-2253.
A June 19 Untitled Letter to Pfizer cited a patient brochure for ZMAX, which it alleged is false or misleading because it:
- Omits and minimizes important risk information
- Makes unsubstantiated superiority claims
- Omits material facts
- Broadens the indication for the product
- Makes misleading efficacy claims
- Makes unsubstantiated claims.
For example, OPDP states that the Zmax brochure “minimizes the risks associated with Zmax by failing to disclose that severe and fatal allergic and skin reactions have been observed with azithromycin.” Even though the brochure states that patients should seek emergency help right away if they develop a series of severe side effects, such as trouble swallowing, hives, swelling of the face or tongue or trouble breathing, “failure to disclose the severity of the potentially fatal allergic reactions, including recurrence of the allergic symptoms even when the drug was discontinued … misleadingly minimizes the risks associated with Zmax,” OPDP states in the letter.
Finally, two Untitled Letters – both sent on June 21 – address testimonials in promotional video segments. An Untitled Letter sent to Acorda Therapeutics Inc. states that a video for AMPYRA Extended Release Tablets is false or misleading because it overstates the efficacy of the drug product and minimizes important risk information. In the video, a patient discusses her experience with and treatment for multiple sclerosis and makes statements that may reflect her personal experience, but are not supported by substantial evidence, according to OPDP.
The letter to Acorda also states that statements made in the testimonial minimize risks associated with Ampyra. “Specifically, they imply that patients who experience adverse events, such as paresthesia and insomnia, will be ‘able to get used to it’ and such adverse events will disappear within a month,” the letter states, and “the overall effect of the risk presentation undermines the communication” of important risk information.
In its Untitled Letter to Valeant Pharmaceuticals North America, OPDP alleges that a patient assessment video and a Web page for XENAZINE Tablets for Oral Use are false and misleading because they overstate efficacy, omit material facts and omit and minimize the serious risks of the drug.
The video, in which a case study of one patient is presented showing “before and after” shots, overstates the product’s efficacy, the letter states. These presentations “are misleading because they suggest that treatment with Xenazine will lead
to significant improvements in balance, walking and postural stability in patients with Huntington’s disease, when such benefits have not been demonstrated by substantial evidence,” the letter states.
OPDP also takes issue with the nearly four-minute video presenting many claims regarding the efficacy of Xenazine while minimizing its risks and “failing to convey any risks associated with Xenazine during this audio-visual presentation” (emphasis original). The letter also states that the video seemingly ignores the boxed warning, contraindications, warnings and precautions associated with the drug. Further, the Web page where the patient assessment video is located “completely omits the risk of clinical worsening and adverse effects associated with Xenazine and the increased risk of somnolence and sedation with concomitant use of alcohol or other sedating drugs.”
Several of the letters issued during this period echo problems cited by OPDP in the first quarter of 2012. In an enforcement update held at the end of April, OPDP Regulatory Counsel Ernest Voyard clarified that patient case studies used for promotional purposes should reflect the general use of the product as listed in the PI. “Companies shouldn’t pick extreme cases that show a clear benefit and hide the risk. It should be an accurate reflection of what patients should expect,” he said. “That being said, it doesn’t have to be a middle-of-the-road patient either, but it should reflect what’s expected.”
Case studies focusing on outlier patients are “probably dangerous,” Voyard noted. “The exceptional patient is an outlier, and any outlier can be problematic,” he said. “A [case study] patient has to experience some of the benefits and some of the risks – not necessarily every benefit and every risk
– but the [case study patient] should address the general experience.”
July 12,
2012 – In a July
12 entry on his DrugWonks.com blog, Center for Medicine in the Public Interest Co-founder and President Peter Pitts discusses how Eli Lilly & Co. is using social media to its advantage. This example is significant, because many pharmaceutical companies continue to struggle with how – and how much – to involve social media in their promotional strategies.
Read more at: http://drugwonks.com/blog/a-little-guilding-of-the-eli-lilly
July 10, 2112–FDA yesterday announced many details of its long awaited guidance to sponsors of pain drugs under the mandatory REMS requirement. While these drugs improve the quality of life for many patients suffering from serious pain, they are also addictive and subject to misuse and abuse by others.
Read the following blog entry published today by Policy and Medicine for more details, and stay tuned for more information on how both promotional education and certified CME will play a major role in this education.
John Kamp, Executive Director, Coalition for Healthcare Communication
| FDA Releases Final Risk Evaluation and Mitigation Strategies (REMS) for Extended Release/Long Acting Opioids Including a Prescriber Education Program
Posted: 09 Jul 2012 07:47 PM PDT
After three years of work the Food and Drug Administration (FDA) released its final Risk Evaluation and Mitigation Strategies (REMS) for extend-release (ER) and long-acting (LA) opioid medications. This is the first time that the FDA has mandated a class wide REMS and much of what is recommended will be looked at closely for future class REMS.
ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions (list of ER/LA opioid products). The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overdose, and death.
After input from many stakeholders dating back to November 2011, the Food and Drug Administration (FDA) also released the “Blueprint for Prescriber Continuing Education Program” regarding the use of opioids. The Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS).
A REMS is a risk management plan that goes beyond requirements in the drug prescribing information to manage serious risks associated with a drug. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require companies to develop and implement a REMS when necessary to ensure that the benefits of a drug or biological product outweigh its risks.
The CME Coalition offered its strong support for FDA’s efforts. Andrew Rosenberg, Senior Advisor to the CME Coalition stated, “When there is a public health imperative, such as the abuse of long acting opioids, continuing education of providers is integral to improving patient outcomes and advancing the health of the country.” Rosenberg continued, “We are pleased that the FDA views CME as a change agent and valuable resource to improve caregiver behavior in this vital area.”
FDA’s final REMS is important because it marks a crucial step in federal health care agencies for recognizing the importance of CE and continuing medical education (CME). The Agency’s logical and reasoned approach towards working with industry and accredited CE providers is a significant step in the right direction not only for patients and physicians but for the future of our healthcare system. The opioid REMS represents the cross-collaboration of CE providers, industry, consumers, patients, and FDA. Moving forward, FDA and these stakeholders should look at other opportunities to collaborate and use CE/CME to improve patient outcomes, reduce healthcare costs, and lower safety risks.
Background
Opioids are widely prescribed and carry a risk of abuse, misuse and death. In 2009, there were nearly 425,000 emergency department visits involving non-medical use of opioid analgesics. According to estimates from the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioid pain relievers in 2008. In 2009, there were 15,597 deaths involving an opioid medication.
The REMS is part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic. The REMS introduces new safety measures designed to reduce risks and improve the safe use of ER/LA opioids, while ensuring access to needed medications for patients in pain. FDA is requiring a REMS for ER/LA opioid analgesics because FDA has concluded that there is a disproportionate safety problem associated with these products that must be addressed.
“Misprescribing, misuse, and abuse of extended-release and long-acting opioids are a critical and growing public health challenge,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids and that patients know how to safely use these drugs.”
All ER/LA opioid analgesics will be required to have a REMS. The new ER/LA opioid REMS will affect more than 20 companies that manufacture these opioid analgesics. Under the new REMS, companies will be required to make education programs available to prescribers based on an FDA Blueprint. It is expected that companies will meet this obligation by providing educational grants to accredited continuing education (CE) providers to offer training to prescribers at no or nominal cost. These CE activities must cover the content and messages of a blueprint developed by FDA for this purpose.
The REMS also will require companies to make available FDA-approved patient education materials on the safe use of these drugs. The companies will be required to perform periodic assessments of the implementation of the REMS and the success of the program in meeting its goals. The FDA will review these assessments and may require additional elements to achieve the goals of the program.
“We commend the FDA for taking action to save lives by increasing access to prescriber education,” said Gil Kerlikowske, director of the Office of National Drug Control Policy. “Since day one, the Obama Administration has been laser focused on addressing the prescription drug abuse epidemic and today’s action is an important contribution to this comprehensive effort.” The new ER/LA opioid analgesics REMS is also part of the national prescription drug abuse plan announced by the Obama Administration in 2011 to combat prescription drug misuse and abuse.
ER/LA opioid analgesics are widely prescribed medicines with an estimated 22.9 million prescriptions dispensed in 2011, according to IMS Health, which provides services and information to the health care and pharmaceutical industries. It is estimated that more than 320,000 prescribers registered with the Drug Enforcement Administration (DEA) wrote at least one prescription for these drugs in 2011.
ER/LA opioid analgesics are associated with serious risks of overuse, abuse, misuse and death and the numbers continue to rise. According to the Centers for Disease Control and Prevention, 14,800 Americans died from overdoses involving opioids in 2008. In 2009, there were 15,597 deaths involving these medications – nearly four times as many deaths compared to 1999.
“There are a limited number of options available for the treatment of pain. Opioids are one option, but they carry a significant risk of misuse, abuse, overdose and death,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction Products. “We’re trying to help physicians manage the risks and improve the safety of using these medicines.”
“Misuse and abuse of prescription opioids is a complex problem and demands a holistic response,” said John Jenkins, M.D., director of CDER’s Office of New Drugs. “The new REMS program is one component of a multi-agency, national strategy to address this important public health issue.”
Role of CME
The central component of the ER/LA opioid analgesics REMS is an education program for prescribers (e.g., physicians, nurse practitioners, physician assistants). There are approximately 320,000 prescribers of ER/LA opioid analgesics in the United States, and FDA expects companies to train 25% of these prescribers at the end of the first year following implementation of the program, 50% after two years, and 60% of them within three years of the start of training.
It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013. The FDA expects the training to take approximately 3 hours, but the CE providers will determine the number of CE credit hours that will be offered for the courses based on established standards for such determinations. Key components of the ER/LA opioid analgesics REMS include:
- Training for prescribers. Based on an FDA Blueprint, developed with input from stakeholders, educational programs for prescribers of ER/LA opioids will include information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, and counseling patients on the safe use of these drugs. In addition, the education will include information on how to recognize evidence of, and the potential for, opioid misuse, abuse, and addiction, and general and specific drug information for ER/LA opioid analgesics.
- Updated Medication Guide and patient counseling document. These materials contain consumer-friendly information on the safe use, storage and disposal of ER/ LA opioid analgesics. Included are instructions to consult one’s physician or other prescribing health care professional before changing doses; signs of potential overdose and emergency contact instructions; and specific advice on safe storage to prevent accidental exposure to family members and household visitors.
- Assessment/auditing. Companies will be expected to achieve certain FDA-established goals for the percentage of prescribers of ER/ LA opioids who complete the training, as well as assess prescribers’ understanding of important risk information over time. The assessments also cover whether the REMS is adversely affecting patient access to necessary pain medications, which manufacturers must report to FDA as part of periodic required assessments.
It is expected that the first continuing education activities under the REMS will be offered to prescribers by March 1, 2013.
Follow-up surveys will be conducted to assess prescriber understanding of the important safety information and assess whether the REMS is adversely affecting patient access to necessary pain medications. Companies plan to offer additional funding to CE providers as an incentive to identify and track prescribers who take the REMS-compliant training and to perform follow-up surveys to assess the amount of information retained.
As part of the REMS, companies will report periodically on actions taken to implement the REMS, including, for training provided by CE providers, the number of grants awarded to CE providers, the number of prescribers trained, and other relevant information. If FDA determines that the REMS is not meeting its goals, the Agency will re-evaluate the program.
There is no mandatory requirement that prescribers take the training and no precondition to prescribing ER/LA opioids to patients. However, the Obama Administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 as part of its comprehensive plan to address the epidemic of prescription drug abuse. The program, which would be linked to DEA registration by providers, would require legislative changes that are being pursued by the Administration.
The FDA continues to support this approach, but absent the needed legislation, intends to exercise its authority to require mandatory elements for companies and voluntary elements for prescribers – all of which are important and necessary steps to help curb the misuse and abuse of ER/ LA opioid analgesics, without being overly burdensome.
For patients, the benefit is two-fold. First, Hertz notes that health care professionals who participate in the REMS
program will have more knowledge and awareness and can have frank conversations with their patients about the risks and appropriate use of opioids. A new patient counseling document will be available for prescribers to use when talking to their patients about these medications.
The REMS also includes an updated Medication Guide—a paper handout for patients that the pharmacist will provide when a patient receives an ER/LA opioid medication. This document, Hertz says, is written in plain language to simply explain how to safely use ER/LA opioid medicines.
The American Academy of Pain Medicine, which represents 2,600 pain physicians and treatment teams, issued a statement supporting FDA’s issuance of the REMS for opioids, calling it a “huge leap forward.”
“Through proper education and training, opioids can be administered safely to patients and continue to be an important option in the treatment of chronic and debilitating pain that is suffered by millions of Americans.” AAPM will also shortly be issuing a series of best practices for both patients and prescribers that can further reduce adverse outcomes associated with opioids.
Purdue Pharma L.P., maker of several opioids including OxyContin®, also announced its viagra online without prescription support for FDA’s REMS for opioids.
|
July 10, 2012 — Last week the Massachusetts house and senate passed revisions to their 2008 Pharmaceutical and Device Manufacturer Code of Conduct (PCOC) as part of the 2013 state budget. A partial repeal of the PCOC, also known as the “gift ban,” will permit companies to cover expenses for medical device training as well as meals for non-CME presentations at locations other than hospitals, medical offices and training sites. The revisions also will eliminate state reporting for physicians that duplicates federal Sunshine Act reporting, according to an article in Policy and Medicine.
“While transparency is a laudable goal, it’s never too late to recognize that legislation has gone too far. Congratulations to the leaders of Massachusetts for recognizing that and for taking a step back in the right direction,” said John Kamp,
Coalition for Healthcare Communication Executive Director.
To read more, go to: http://www.policymed.com/2012/07/massachusetts-passes-partial-repeal-of-the-pharmaceutical-and-device-manufactures-code-of-conduct-ak.html
July 6, 2012 – In the aftermath of the July 2 announcement of a $3 billion settlement between GlaxoSmithKline and the U.S. Department of Justice – in part due to allegations that GSK promoted off-label uses – the Food and Drug Administration needs to take a fresh look at its off-label promotion policy, according to Coalition for Healthcare Communication Executive Director John Kamp.
“Doctors and patients need to know the latest scientific evidence on the effective and safe use of drugs, but the antiquated FDA rules on off-label communication prohibit companies from fully educating them,” Kamp said. “It’s time to put
a stop to these prosecutions. They impede doctor education and patient care and likely violate the First Amendment.”
In the recent settlement, GSK resolves previous criminal and civil liabilities. Under the settlement’s terms, GSK will plead guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act related to the marketing of Paxil for pediatric use and of Wellbutrin for certain uses, as well as a failure to include information about the initiation or status of certain Avandia studies.
“Today brings to resolution difficult, long-standing matters for GSK,” GSK CEO Sir Andrew Witty said in a July 2
statement. “Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.”
Kamp added that “policy makers and the public should understand that GSK is fully compliant today with the government’s censorship mandates and has been for many years.”
Current agency policy allows health professionals to prescribe drugs for off-label use, but does not allow manufacturers to communicate with doctors and patients about these off-label uses to consumers. Under these rules, all health professionals and others – except the drug sponsor – are allowed to engage in communications about the off-label use. “The fact that this rule restricts the speech of none but the drug sponsor violates consistent decisions by the Supreme Court, including the recent IMS ruling,” explained Kamp.
Moreover, in its most recent draft guidance on off-label promotion, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” issued Dec. 27, 2011, the agency describes the legal framework for the agency’s restrictions on off-label speech, but stipulates that “these off-label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care.”
In Kamp’s view, the government must move forward to enable drug companies to fully participate in education and communication about new uses of approved drugs. Without this, doctors and patients are not as likely to have full information about the safety and effectiveness of available medical options. However, Kamp acknowledges that changes to current policy may require Congressional action.
“It is in the best interest of patients everywhere that the FDA revisits its off-label policy swiftly,” he noted. If the agency does not, it may be time for the U.S. Supreme Court to settle the matter, he explained. “I’m optimistic that federal appeals courts and the Supreme Court will step in to review the off-label censorship of drug companies under the mandates of the First Amendment,” he said.
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