REMS As A New Competitive Sword?

paradiseLGjpg_1The pharmaceutical industry has long-been criticized for use of anticompetitive tactics.  Brand pharmaceutical companies have been publicly accused of several high-profile activities to increase profits and stifle competition.  These include: shifting demand to a modified form of an existing brand drug (often called “product hopping”), using authorized generics to retain market share, frivolously filing citizens petitions to delay generic market entry, and using reverse payment settlements to keep generics of the market during their 180 day exclusivity period (otherwise known as pay-for-delay settlements).  A persistent opponent in these tactics, the Federal Trade Commission (FTC), routinely invokes antitrust and unfair competition law to frame legal challenges.  In fact, the 2012 Supreme Court case FTC v. Actavis examined pay-for-delay settlements entered into between new drug application (NDA) patent holders and generic applicants, holding that they were not per se illegal but subject to a rule of reason test.

Many are now pointing to brand pharmaceutical manufacturers use of Risk Evaluation and Mitigation Strategies (REMS) as the latest anticompetitive tactic.  The Food and Drug Administration Amendments Act of 2007 (FDAAA) introduced REMS to enhance the FDA’s post-approval authority over drugs.  FDAAA contains new statutory provisions that allow the FDA to require further studies for safety and efficacy, along with increased authority for FDA to review these commitments on a continuing basis.  The FDA can require a REMS as either a condition of approval or, in the case of already approved products, as a subsequent additional condition for continued marketing.  A REMS may require a medication guide for patients, prescription physician information, communications to health care providers and pharmacies, limitations on labeling, promotion, and prescribing in order to assure safe use by patients, and a plan for implementation.  Violations trigger civil money penalties and subject manufacturers to litigation under misbranding provisions within the Food, Drug and Cosmetic Act.  To date, the FDA has implemented 70 REMS, half of which include elements to assure safe use (ETASU) that often take the form of distribution restrictions, training and recordkeeping requirements for prescribers and pharmacists, and prescribing limitations.

As noted here, a recent study announced last month estimates that $5.4 billion per year has been lost in prescription drug savings due to distribution restrictions imposed by brand drug manufacturers.  Brand manufacturers subject to a REMS for an NDA drug product claim that they cannot make samples of that drug available to the generic applicant because they would be in violation of distribution restrictions placed on the products by the FDA in the REMS.  However, in order to obtain approval through the generic drug approval process, a generic applicant must show bioequivalence to the NDA product through pharmacokinetic and pharmacodynamic measures.  The medical community is already targeting this practice as problematic, noting that it is a direct threat to the effective use of a drug-safety tool in order to increase profits and keep generic products off the market. In an April 2014 New England Journal of Medicine article, excerpted here, the authors urge that “the use of REMS requirements to block the market entry of generic drugs could well lead to higher health care costs and adverse patient outcomes.”

The REMS tactic is playing out in court in New Jersey.  Mylan Pharmaceuticals filed a complaint earlier this year against Celgene Corporation, claiming violations of federal antitrust law.  Mylan alleges that Celgene refuses to distribute the products Thalomid and Revlimid for bioequivalence testing for products in development by Mylan.  Because of their teratogenic nature, the FDA has invoked ETASU REMS for both Thalomid and Revlimid consisting of various extensive requirements to prevent embryo-fetal exposure, among other things: see here and here.  One aspect of the ETASU is strong oversight and requirements for distribution only through authorized dispensing pharmacies.  Celgene’s position is that the distribution restrictions prohibit the transfer of drug samples to Mylan for any purpose, including bioequivalence studies.

The FTC has taken a strong interest in the case, and filed an amicus brief on June 17, 2014.  In the brief, the FTC argues that Celgene is potentially engaging in exclusionary conduct in violation of the Sherman Act by “refusing to sell to rivals.”  The FTC notes that Celgene may be in violation of both Section 1 and  2 of the Sherman Act by not only refusing to directly provide samples to Mylan, but also implementing restrictions that prevent Mylan from purchasing samples though customary distribution channels.  Celgene has moved to dismiss.


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


Restricted Provider Networks and Patient Access: The Need for Contextual Analysis

jacobi_johnTheresa Brown’s op-ed in the New York Times on Sunday, title “Out of Network, Out of Luck,” raised concerns about patients’ access to physicians within a restricted provider network.  Brown describes the market in Pittsburgh, where two large hospital systems, each with an allied health plan, are battling for market share, leaving some patients with a painful choice: leave their treating physician, sometimes during a course of care, or pay higher out-of-network fees.  Brown notes that the hospital systems’ integration with payers, and their aggressive swallowing up of physician practices, are steps taken in furtherance of the goals of cost containment and quality improvement.

The piece highlights the growing problem of network adequacy in health plans.  The Affordable Care Act’s goal is expanded coverage, but it encourages some mechanisms to restrain cost.  For example, health insurance exchanges’ lower-than-expected premiums resulted in part from insurance plans’ restrictive provider networks.  The business proposition for narrow networks has been clear for decades, as plans can offer providers patient volume in return for price concessions.  This dynamic is complicated, as Professor Tim Greaney has described, near-monopsony power of insurers  in some states, and hospital system mergers undertaken in reaction to insurer power, but which can also have anti-competitive effect.

As the Pittsburgh situation demonstrates, powerful hospital systems and insurance plans will duke it out for market power, but may also combine in new, hybrid organizations.  As the battleground moves from fee-for-service to more sophisticated reimbursement tools such as global payments, the elbows will get sharper, and the competition that remains will likely narrow patient choices even further.   Massachusetts, the precursor in so much that is cutting edge in health policy, is showing the way.  As Mechanic, Altman, and McDonough described last year, substantial pressure from plan sponsors and government have led provider systems to cooperate in programs that narrow patient choice, in the interest of restraining cost.

Is this a bad thing?  Read more


Tara Ragone in Modern Healthcare on potential impact of U.S. Supreme Court hospital antitrust decision

March 5, 2013 by · Leave a Comment
Filed under: Antitrust, Health Law 

tara-ragoneResearch Fellow & Lecturer in Law Tara Ragone appeared in Modern Healthcare on the potential impact of a recent U.S. Supreme Court decision which found a hospital not exempt from antitrust scrutiny, despite its claim to be protected from such through “state action immunity doctrine,” which, according to Modern Healthcare, “gives states wide latitude to regulate competition.”

The Court’s decision was unanimous, citing the fact that although the hospital system in question, Phoebe Putney Health System, “operates public hospitals under a $1-a-year lease from the Albany-Dougherty Hospital Authority,” it did not dispute that its latest hospital acquisition would give it “control of 86% of  a six county market after the sale.” The Court, according to Modern Healthcare, ruled that Phoebe Putney’s financial relationship with the state was not sufficient to render its state action immunity defense tenable, and that “states must expressly grant antitrust immunity to local entities.”

The Modern Healthcare article notes, however, that the decision may also have impact on Medicaid ACOs under the ACA.

Modern Healthcare writes:

And it also could affect Medicaid ACOs. “The state action doctrine has been expanded, expanded, expanded to essentially immunize them,” [Matthew] Cantor said. “The Supreme Court is going to look a bit wary about stark anti-competitive behavior.”

But Tara Adams Ragone, a research fellow and lecturer at Seton Hall University School of Law who has written about how to structure Medicaid ACOs to avoid antitrust scrutiny, noted that the laws in New Jersey, New York, Oregon and Washington do state that they intend to authorize anti-competitive behavior.

“It doesn’t change things from my analysis,” she said about the Phoebe Putney decision. Yet she added that states may have to review statutes that don’t contain that explicit language.

The Phoebe Putney decision also doesn’t address the second prong of the state action doctrine, which requires states to actively oversee the anti-competitive behavior. “That’s where there’s a lot of work to be done,” she said.

Ragone and Cantor pointed out that it’s still unclear whether the FTC and U.S. Justice Department even intend to challenge ACOs as anti-competitive. A classic antitrust case involves entities colluding to fix prices—but the whole goal of an ACO is to reduce costs.

Read the full Modern Healthcare article, “Phoebe Putney dealt legal blow by Supreme Court.”


Recommended Reading: Recent Scholarship with Implications for Pharmaceutical Pricing and Access

September 15, 2011 by · Leave a Comment
Filed under: Antitrust, Recommended Reading 


Bundles in the Pharmaceutical Industry: A Case Study of Pediatric Vaccines, by Kevin W. Caves and Hal J. Singer of Navigant Economics, provides a technical but still accessible analysis of the anticompetitive effects of vaccine manufacturers’ practice of conditioning price discounts on physician buying groups agreeing to purchase the manufacturers’ vaccines in a bundle and agreeing not to purchase other manufacturers’ products.  The article begins with an interesting overview of the characteristics of the vaccine market, an introduction to the physician buying groups that purchase vaccines and to the anti-kickback concerns they raise, and a summary of the (somewhat up in the air) legal standard for when bundled discounting becomes an antitrust violation.

The authors then present their analysis of the uphill battle Novartis (a source of funding for the article) will have to fight to induce physicians to “break the bundle” and buy its new meningitis vaccine.  The authors conclude that even if Novartis were to give away its meningitis vaccine for free, “buyers defecting from [Sanofi Pasteur's bundle of vaccines, which includes Sanofi's meningitis vaccine,] would still lose $14.05 per patient in expected value.”  They present data indicating “that buyers unencumbered by … Sanofi’s loyalty contracts are over three times as likely to purchase [Novartis' vaccine], relative to encumbered buyers…” and conclude that enough of the market is foreclosed to Novartis to establish a presumption of anticompetitive effects and concomitant harm to consumers.  Per the authors, “[i]n an industry served almost exclusively by large, multi-product incumbents, with no prospects for generic competition and extremely limited entry by competitive rivals of any kind, these findings have significant implications for public policy and antitrust enforcement.”

Somewhat less accessible (due to a plethora of equations) but still well worth reading is Tort Liability and the Market for Prescription Drugs by Eric Helland, Darius Lakdawalla, Anup Malani, and Seth Seabury.  Helland and his co-authors present the results of an empirical study of the relationship between product liability rules and drug price and utilization.  While the effect of a liability rule can often be studied by comparing a state that makes a change to the rule with one that does not, the authors had to modify this approach because drugs are sold nationally.  They determined the exposure to punitive damages caps of each of nearly 16,000 drugs by first determining each drug’s geographic distribution of sales, a figure which varies from drug to drug due to geographic variation in the prevalence of disease.  The authors found that the degree of exposure to caps was correlated with an increase in drug prices but also with an increase in drug utilization.  Tighter liability standards also correlate with a reduction in adverse drug reactions.  The authors write that their numbers “imply that if every remaining state adopted some reform, there would be a 23% increase in all [adverse] events and a 25% increase in serious [adverse] events … among branded drugs.”  They conclude that “on balance, liability improves consumer and social welfare.”


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