Hatch-Waxman Comments – Status Report (Part I)

What are people recommending that FDA do, to improve the current balance between drug innovation and access to generic drugs?  The docket isn’t closed yet, but I’ve read the first 67 comments. . . .

Background

FDA held a public meeting in July to consider the Hatch-Waxman Amendments, asking for comment concerning its administration of the amendments “to help ensure the intended balance between encouraging innovation in drug development and accelerating the availability to the public of lower cost alternatives to innovator drugs is maintained.”  It also opened a docket for written comments, which was originally slated to close on September 18.  On September 19, it extended the date for submission of comments to November 17.   What follows is a high level overview of some of the main recommendations for FDA in the first 67 comments.

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Data Exclusivity for Medical Devices

Data exclusivity for drugs and biological products gets all the attention.  (In fact, recently I read a law review article asserting that medical devices are not entitled to any sort of exclusivity period after approval.  But this is wrong!)  It is apparently not as well known, but sponsors of premarket approval applications (PMAs) enjoy six years of data exclusivity.  Folks interested in FDA and innovation policy should know about the device scheme because it has a unique history (with a novel and clever – though unworkable – approach in place for seven years) and because at a high level it is still analogous to drug and biologic exclusivity even though the regulatory paradigms are different.

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FDA Law SSRN Reading List (August 2017)

Here’s a round up of FDA-law related readings posted to SSRN in August.

This excludes articles that were published before 2017 but posted on SSRN for the first time in August 2017.  It also omits pieces for which the abstract, but not the article, was posted.  As a result, for instance and unfortunately, it does not include Professor Jordan Paradise’s new piece, Regulatory Silence at the FDA: Impact on Drug and Biologic Competition.  The abstract indicates she explores the agency’s “reluctance” to wade into issues relating to patent law as well as the contribution of this “silence” to anti-competitive action that harms consumers.

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FDA’s Reliance on User Fees

Cross-posted on Notice & Comment.

On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use.  These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA (biosimilars), and MDUFMA (medical devices).

The White House had been urging Congress to change the structure of FDA’s user fee programs so that much of the agency’s programming is funded by user fees rather than appropriations.  Congress has more FDA user fee programs to reauthorize, however, and the Administration’s basic proposal is unlikely to go away.  I explain more of the history and the debate below.

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ANDAs before Hatch-Waxman

Three times in the last two weeks, I have found myself explaining to someone that the Hatch-Waxman Amendments did not create the abbreviated new drug application for generic drugs.  For that matter, there were generic drugs long before 1984, and there was a generic industry long before 1984.  And that’s not even the most interesting part; at one point, FDA drafted a regulation for an ANDA pathway that would apply in the future to new NDAs and that would provide a 17-year exclusivity period.

This blog entry explains a little of the history.

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FDA Law SSRN Reading List (July 2017)

I plan to capture monthly the papers posted on SSRN that relate directly to FDA law (other than those written by me or Patti).  Here is the July 2017 edition.

Michael Carrier, Carl Minniti, and Brenna Sooy, Five Solutions to the REMS Patent Problem, forthcoming in Boston University Law Review.  There have been a number of articles exploring whether and to what extent innovators are somehow inappropriately benefiting from the access restrictions imposed by FDA under a “Risk Evaluation and Mitigation Strategy” (REMS).  Professor Carrier’s piece (co-authored with two students) makes a contribution by diving more deeply into one specific issue — the fact that several innovators with access restrictions hold patents claiming an aspect of the REMS.  Table 1 helpfully lists the 23 patents associated with REMS for five innovative products, which the authors found in the Orange Book.  The authors believe that a generic company seeking to copy a drug with a REMS protected by patent will be “stuck between the rock of FDA law and hard place of patent law” — essentially that the generic company will have no choice but to infringe.  They offer five solutions. First, they argue that REMS patents should not be listed in the Orange Book — which as a practical matter would mean that a generic applicant would not have to challenge it and (more importantly) that the patent could not give rise to an automatic 30-month stay of generic drug approval.  Second, they suggest that REMS patents may be invalid and urge use of inter partes review.  Third, they argue that in the event of infringement, an injunction should not issue.  Fourth, they propose amendments to the REMS provision of the FDCA that they believe will prevent REMS patents from blocking generic competition; the article helpfully includes the legislative language in question.  Finally, they propose that the patent act be amended so that risk management methods and systems are insufficient to differentiate a claimed invention from the prior art.  (Professor Carrier also posted slides that he presented at FDA’s recent hearing on the Hatch-Waxman Amendments; here, too, he offers proposals relating to REMS.)

Lindsey M. Edwards, The Need for Clarification on Product Hopping: Open Questions after Namenda and Doryx.  Ms. Edwards is a 2017 graduate of the Antonin Scalia Law School and will be joining Wilson Sonsini in the fall.  This brief piece published by the ABA Section of Antitrust Law summarizes two leading cases on “product hopping,” which she defines as making “an incremental change to the formulation of a drug in order to extend its exclusivity period.”  In very simple terms (mine, not hers), the allegation of “product hopping” arises when an innovator that has been marketing Brand 1.0 of its product introduces Brand 2.0.  Under the FDCA, a generic copy of Brand 1.0 can still be approved exactly when expected, but the concern arises when, for one reason or another, physicians and patients have switched to innovator’s Brand 2.0.  Generic drug companies generally rely on automatic substitution (under state pharmacy law) to achieve market penetration — meaning the automatic substitution of Generic 1.0 when a physician writes a prescription for Brand 1.0.  If physicians are now prescribing Brand 2.0, that won’t happen.  There can be variations and nuances to this basic fact pattern, and there are strongly held views on both sides of the question whether anything anti-competitive has happened.  Ms. Edwards describes two significant recent cases that came out differently in the courts of appeals (one involving Namenda and one involving Doryx), and she spends some time discussing what the courts analyzed differently (the importance of state substitution law to market penetration being one of them).

August will bring many more articles to read.

The Unapproved Drugs Conundrum

In recent years there have been a few high profile situations in which the price of a medicine has jumped sharply and suddenly, after decades of availability at a much lower price.  In some of these cases — like the case of gout treatment colchicine, which went from 10 cents to five dollars per pill in 2011 — the sudden price increase relates to FDA’s “unapproved drugs initiative.”  This refers to the agency’s approach to removing unapproved new drugs from the U.S. marketplace.

This blog entry explains the back story and the public policy conundrum that merits some attention.

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The Logical Outgrowth Doctrine and FDA’s Intended Use Revisions

Cross-Posted on Notice & Comment

In January FDA published a controversial revision to its regulations defining a product’s “intended use” that, among other things, has raised an interesting logical outgrowth question. “Intended use” is an important concept in FDA law because a product’s intended use—judged by the “objective intent of the persons legally responsible for the [product’s] labeling”—can be crucial to determining whether a product is a drug or device subject to FDA oversight at all, and whether an FDA-authorized drug or device is in compliance with FDA requirements. (Readers can find more about “intended use” generally, and the background behind the current controversy, here). Because “intended use” is so important in the FDA world, it should come as no surprise that stakeholders that disagree with the revised definition in the January final rule—which has yet to go into effect—have lodged both procedural and substantive arguments against the revision (see, e.g., here and here).

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NASEM Report on Pain Management and the Opioid Epidemic

Disclosure: I served as a consultant to the Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse.

Last year, FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to appoint a committee to study the role of opioids in pain management and the opioid epidemic, and, among other things, to provide the agency with recommendations on the options available to it to address the epidemic. Today that committee’s report was released.  As noted above, I served as a consultant to the committee—and I will let the report speak for itself. But there is a lot in the report that may be of interest to the FDA law and policy crowd, and I look forward to hearing reactions to the report and the recommendations included in it.

Could FDA Enforce the “Requirement” to Provide the Biosimilar Marketing Application ?

I am writing again about the Supreme Court’s June 12 ruling that Amgen was not entitled to a federal injunction ordering Sandoz to share its biosimilar marketing application and manufacturing information.  The Court’s opinion refers ten times to providing those materials as “required” or a “requirement” (Slip Op. at 2, 4, 7, 9, 10, 13, 13, 14, 15, and 15).  What does this mean, as a practical matter?

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