FDA Grants Citizen Petitions, Promising More Guidance on Off-Label Promotion

Tara RagoneIn a letter to counsel dated June 6, 2014, the Food and Drug Administration (FDA) granted citizen petitions that asked the agency to clarify its regulations and policies regarding truthful, non-misleading scientific communications and activities related to investigational new drugs and devices.

In particular, as part of a general commitment to “engage in a comprehensive review of the regulatory regime governing communications about medical products,” FDA agreed to provide greater regulatory clarity in four specific areas:


  1. Manufacturer responses to unsolicited requests;
  2. Scientific exchange;
  3. Interactions with formulary committees, payors, and similar entities; and
  4. Dissemination of third-party clinical practice guidelines.

It is not clear why FDA decided to release this letter now.  21 C.F.R. 10.30(e)(2)(i) generally requires FDA to respond to citizen petitions within 180 days, and when it approves a petition, “the Commissioner shall concurrently take appropriate action (e.g., publication of a Federal Register notice) implementing the approval.” The petitions were initially filed on behalf of members of the Medical Information Working Group (MIWG) on July 5, 2011 and then supplemented on September 23, 2013 – far longer than 180 days ago.  And although the agency has approved the petitions, it is not concurrently taking appropriate action to resolve all of the issues raised by them.

In fairness, FDA already has taken steps to address some of the issues raised in the petitions.  In December 2011, the agency issued a draft guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (Unsolicited Requests Draft Guidance).  Later that same month, the agency published a request for information and comments regarding its policy regarding “scientific exchange about both unapproved new uses of products already legally marketed (‘off-label’ use) and use of products not yet legally marketed for any use.”

Then in February 2014, the agency released a revised draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices,” which proposes to revise the agency’s 2009 Good Reprint Practices Guidance.  Pertinent to the citizens petitions, this draft guidance revises FDA’s recommendations for distributing scientific and medical reference texts and adds recommendations regarding distributing third-party clinical practice guidelines.  (See summary prepared by McDermott Will & Emery here.)

At the same time that it granted the citizens petitions, FDA also issued “Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products–Recommended Practices,” which addresses the dissemination of risk information for approved prescription drugs and biological products.  (See summary prepared by Ropes & Gray, one of the outside counsel to the MIWG, and early commentary here.)

But the agency acknowledges in its June 6, 2014 letter that several issues raised in the petitions remain unresolved.  A considerable chunk of the letter reviews the background of the regulatory framework created by the Federal Food, Drug, and Cosmetic Act and the agency’s general goal to harmonize its “fundamental interest” in protecting public health with “First Amendment interests in the dissemination of truthful, accurate, and non-misleading information regarding medical products.”  But there is minimal substantive discussion in the letter of how the agency is resolving the questions raised by the petitions and recent First Amendment case law developments, such as United States v. Caronia.

It is clear the agency is continuing to wrestle with how to balance its regulatory goals with constitutional principles.  For sure, there are indications that the agency is retreating somewhat from its prior stance that manufacturer dissemination of off-label information is almost always off-label promotion and, therefore, impermissible. Indeed, FDA expressly acknowledges in its letter that “there can be utility in the dissemination of truthful and non-misleading scientific or medical information regarding off-label uses under appropriate circumstances.”

The agency’s response, however, leaves many questions unanswered, including the contours of these “appropriate circumstances.”  FDA continues to consider comments submitted in response to the draft guidance documents described above, and the public will have 75 days from publication in the Federal Register of the most recent draft guidance to comment.  The agency commits in the letter to release guidance by the end of 2014 addressing “unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally.”  It also intends to issue a draft guidance by the end of the year in response to the MIWG’s requests concerning health care economic information, which industry has been anxious to receive.

Without question, FDA’s letter piques the interest of the regulated community and academics, but it also leaves many open issues.  As Ropes & Gray, one of the counsel for the citizens petitions, observed:

It remains to be seen whether any regulatory changes made by FDA will result in additional flexibility or additional scrutiny over manufacturer communications regarding truthful, non-misleading information for approved or cleared products. It also remains to be seen whether FDA can square its current regulatory approach with constitutional requirements.

We will be waiting with bated breath for the promised regulatory guidance.


Recommended Reading: AHLA White Paper “Beneficiary Inducements in an Evolving Market: Assessing the Risks, Understanding the Benefits and Drawing the Lines”

April 25, 2014 by · Leave a Comment
Filed under: Recommended Reading 

CaptureThis white paper reports on a convener session held by AHLA’s public interest committee in October 2013.  The session brought together a diverse array of individuals from government, industry, providers, patient advocates, and academia, including Seton Hall Law Professor John V. Jacobi, to discuss the federal Anti-Kickback Statute and Civil Money Penalty Law’s prohibitions on inducements to beneficiaries and whether any changes to existing law or additional guidance may be appropriate.  In particular, the session considered the applicability of the prohibitions on inducements to a variety of current industry practices that offer the promise of improving health care delivery and access, including wellness programs, patient assistance programs, transportation and lodging assistance, promotion of adherence to treatment regimens, incentives to remain in network, readmission reduction, and end of life–palliative care programs.  Building on the new exception to the Beneficiary Inducement CMP Law in the ACA that protects remuneration that promotes access to care and poses a low risk of harm to patients and federal health care programs, the white paper identifies a number of benefits and safeguards that the government should balance when considering whether to permit beneficiary inducements in certain circumstances.   It reports that “there was a strong sentiment that clearer guidance in this area will enable providers to implement beneficiary inducements that assist the Programs, improve patient care and promote the goals of health care reform.”


Recommended Reading: Houston Law Review Frankel Lecture and Commentaries Offer Valuable Analysis of the Affordable Care Act and Guideposts for Continued Reform

April 23, 2014 by · 1 Comment
Filed under: Recommended Reading 

Tara RagoneAs the ACA’s first open enrollment period closes, a trio of articles in the recent Houston Law Review offers critical analyses of what health reform has accomplished and important reminders of what remains to be done:

1. Mark A. Hall’s Frankel Lecture, Evaluating the Affordable Care Act: The Eye of the Beholder, seeks to provide “a dispassionate analysis of the law’s actual effects . . . to inform those with open minds (however few they might be) about how this major piece of market and social engineering is actually performing.”  To accomplish this analysis, Hall relies on available information to assess the ACA’s progress towards its primary goals “to increase coverage and preserve a decent range of choice in the private market.”  He also evaluates whether the ACA created any unintended consequences, such as employment and insurer effects.  The varied ways states are implementing the law has created a natural, albeit complex, experiment “that should reveal whether health care access and consumer protections improve or worsen in states that fully embrace the law as compared to states that actively oppose it” – so stay tuned.

2. In David Orentlicher’s Commentary, The Future of the Affordable Care Act: Protecting Economic Health More than Physical Health?, he seconds Hall’s data-driven approach to assessing the ACA’s impacts.  But given evidence of a tenuous link between having insurance and being healthy, Orentlicher questions whether the ACA will improve health.  Instead he discusses evidence that socieoeconomic status may bear more on health status than access to health care.  He also faults the ACA for pouring too much money into treatment of disease and investing too little on effective public health interventions.

3. William M. Sage’s Commentary, Putting Insurance Reform in the ACA’s Rear-View Mirror, similarly examines “the pros and cons of connecting insurance reform to health care and health.”   While Titles I and II of the ACA are about expanding health insurance coverage and improving affordability, Title III aims to improve health care delivery and Title IV focuses on improving underlying health.  Like Orentlicher’s observation above, however, Sage notes that health insurance and healthcare are not coterminous and “health care is not the major determinant of health.”  What he views as the ACA’s radical breakthrough — trying to make medical care better and more efficient and to improve public health – may also overreach, given the complexity of each goal. Sage urges us to move beyond insurance reform as swiftly as we can so we can focus on addressing delivery system reform and underlying health, and his conclusion offers some ideas.

In a similar vein to these articles, the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and New Jersey Appleseed Public Interest Law Center are collaborating on a two-year project funded by the Robert Wood Johnson Foundation to assess the ACA’s implementation in New Jersey.  The Sentinel Project moves beyond questions of eligibility for insurance to focus on how effectively health insurers in New Jersey are delivering mandated essential health benefits to consumers under the ACA.  In addition to providing legal advice to consumers who are having trouble securing the medical care they need, the Project also will collect and analyze information from consumers throughout the state to highlight implementation trouble spots and develop recommendations for improving access to essential health benefits. Consumers may contact the Sentinel Project by calling (973) 991-1190 or by sending an email to contact@njsentinelproject.org.


Professional Licensing Boards and Antitrust Liability

February 26, 2014 by · Leave a Comment
Filed under: Antitrust, Litigation and Liability 

Tara Ragone

Cross-Posted at Bill of Health

Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct?  The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.

Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case.  He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here.  Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.

While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review).  Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Read more


Concussion Prevention: When Equal Treatment Might Not Make Good Policy

tara-ragoneI was stunned to learn recently that female lacrosse players, at least in my town in New Jersey, may not wear hard helmets even though male lacrosse players must wear them.  This struck me as ludicrous and unfair.   Both sports involve athletes running around with long sticks, hurling dense rubber balls at high speeds.  It seemed to me that balls and sticks can strike players in the head and players can collide in either sport.  How could we care more about preventing traumatic brain injury (TBI) in boys than in girls?  I was outraged.  But as it turned out, I also was a bit uninformed.  It is not as clear as I thought it would be that we should require girls to wear helmets.

A common objection is that female and male lacrosse are very different sports subject to different rules and requiring different skills.  Male lacrosse involves much more brute physical contact, whereas female lacrosse does not permit body checking and demands finesse.   As a female senior lacrosse player explains, because girls’ lacrosse sticks have shallower pockets, girls “’have to be more skilled with our cradling, . . . [so our] game is more graceful.’”  A male senior midfielder acknowledged that the girls’ “’stick skills are unbelievable’” and that “’the girls’ version is more pure.’”  Some believe there is less need for helmets in girls’ lacrosse because of these differences.  Moreover, there is concern that requiring girls to wear helmets will encourage girls to play more like boys, which would risk losing the valuable uniqueness of girls’ lacrosse.

As much as I want to honor female players’ pride in their skills and finesse, science should drive the policy decision whether to require girls to wear helmets.  Research by Nationwide Children’s Hospital in Columbus, Ohio reveals that girls’ lacrosse has the third-highest rate of concussion among female sports, after soccer and basketball, and “its in-game rate is only about 15 percent less than the rougher male version.”  But what do we know about whether helmets can reduce that risk?  Not enough. Read more


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