Tag: drug labeling

Bioethics News

FDA again Delays Rule to Allow Generic Drug Makers to Change Labels

May 23, 2016

(STAT News) – Once again, the US Food and Drug Administration is delaying the debut of a controversial rule for updating generic drug labeling. The rule would allow generic drug makers to independently update safety warnings, something that only brand-name drug makers can currently do before receiving FDA permission. The agency never set a specific introduction date, but the rule was widely expected to be introduced this spring. But on Wednesday, a notice indicated the publication date was extended until April 2017. In fact, this marks the third time since the FDA proposed its rule in 2013 that the rule has been delayed amid opposition from the pharmaceutical industry and some lawmakers.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Did the Supreme Court Explode Drug Regulation While No One Was Looking? Don’t Panic!

Roland Nadler

Back in 2012, CLB Fellow Matt Lamkin blogged about a case that still haunts our nightmares. In United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that FDA regulations prohibiting off-label marketing of drugs violate the First Amendment … or, at least, hinted at that conclusion. The majority didn’t quite come out and squarely declare drug advertising regulation unconstitutional, much to our relief.

The regulatory state as we know it dodged a bullet in Caronia; ever since, Matt and I have been hoping and praying that the Supreme Court would never take up the case. We scanned the dockets for anything Caronia and, mercifully, it never appeared.

… or did it? What if the Supreme Court snuck Caronia’s holding into a different case, right beneath our noses? What if its holding was even broader than Caronia, threatening not just drug regulation but practically all advertising regulation and professional oversight? What if that case was decided 9-0? What if a leading expert said of the decision that its logic “would roll consumer protection back to the 19th century” … ?

Have you woken up in a cold sweat yet? This isn’t a bad dream. The case is real, and its name is Reed v. Town of Gilbert. But it’s also not quite the boogeyman it sounds like. My view is that the decision certainly goes “bump” in the night, but, much like the monster you once could have sworn lived under your bed, its threat is more imagined than real.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Nuances of Preemption in the Generic Drug Context

On Tuesday, the Supreme Court declined to review a California court’s decision that a plaintiff could sue generic drug companies on certain failure-to-warn claims. If you’ve been following the Supreme Court’s drug-labeling-preemption decisions over the last 5 or 6 years, you might find this news a little surprising at first glance. After all, as I explained in a blog post about a year ago, state failure-to-warn claims are generally preempted by federal law for generic drugs. But, once you dig into the facts of the California case – Teva Pharmaceuticals v. Superior Court – the outcome isn’t all that surprising, and it highlights some of the nuances of when state failure-to-warn-claims are, and are not, preempted in the generic drug context.

So what happened in this case?

Olga Pikerie, the plaintiff, took the generic drug alendronate sodium (brand name: Fosamax), which is indicated for the treatment and prevention of osteoporosis. It turns out that alendronate sodium is associated with a risk of atypical femur fractures, and, unfortunately, Ms. Pikerie suffered a femur fracture in April 2011, after taking the drug from 2006-2011.

After suffering the fracture, Ms. Pikerie sued the manufacturers of generic alendronate sodium on two grounds. The first is that they failed to update the generic drug labeling to match the brand name drug labeling. This distinguishes Ms. Pikerie’s claim from the failure-to-warn claims at issue in Pliva v. Mensing, in which the plaintiff argued that the generic labeling should have been updated independently of the brand name labeling. Because Ms. Pikerie’s claim is consistent with federal law – and the requirement that generic drug labeling be the “same” as the brand name drug’s labeling – the California court concluded that, unlike the claims at issue in Pliva, this claim is not preempted.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Zohydro Update

Since FDA approved Zohydro in October 2013, the drug has been the subject of quite a bit of controversy.  In short, the concern is that Zohydro will contribute to the serious prescription drug abuse problem in the U.S. because, as an extended-release drug, it contains a higher dose of hydrocodone than other hydrocodone drugs on the market, and it lacks abuse-deterrent properties (see, e.g., this New York Times blog post).  Perhaps the most interesting part of this controversy is that Massachusetts has attempted to ban the use of Zohydro in that state—which I think makes Massachusetts the first state to flat-out ban an FDA-approved drug.

As we discussed in our recently posted April podcast, Zogenix Inc., Zohydro’s sponsor, sued Massachusetts over this ban (here’s the complaint).  When we recorded the podcast, the federal judge – Judge Rya Zobel of the District of Massachusetts – had not yet ruled on Zogenix’s motion for a preliminary injunction, and I predicted that she would not enjoin Massachusetts from enforcing the ban on preemption grounds.  Well, I was wrong.  On April 15th, Judge Zobel enjoined Massachusetts from enforcing or implementing its Zohydro ban because she concluded that Massachusetts “obstructed the FDA’s Congressionally-given charge” when it “interposed its own conclusion about [Zohydro’s] safety and effectiveness” (here’s the order).

To back up a bit, the Supremacy Clause of the Constitution provides that federal law is the “supreme Law of the Land . . . Laws of any State to the Contrary notwithstanding.”  In other words, as Judge Zobel explained, “state law that conflicts with federal law is without effect.”

Under Massachusetts law, when the Governor declares a public health emergency, the Commissioner of the Massachusetts Department of Public Health may take action that she deems necessary to “assure the maintenance of public health and prevention of disease.”  Pursuant to this law, Governor Deval Patrick declared a public health emergency in response to the “growing opioid addiction epidemic,” and directed the Massachusetts Public Health Commissioner to take a number of actions, including prohibiting the “prescribing and dispensing” of Zohydro until “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.”  Meaning that – according to Zogenix’s complaint — Zohydro must be re-formulated with abuse-deterrent properties before it could be used in Massachusetts.

Because prescribing and dispensing are traditionally thought of as part of the practice of medicine, which, in turn, is generally considered to be regulated by the states, I thought that the Massachusetts ban might be crafted cleverly enough to dodge the preemption bullet.  In other words, I think there is an argument that the Massachusetts ban did not conflict with federal law, because the Massachusetts ban regulated medical practice, while federal law regulates the medical product.  (Kate Greenwood, of Seton Hall Law, made a similar point in a Health Reform Watch blog post.)

But Judge Zobel did not see it that way, concluding that Zogenix is likely to prevail on the merits of its claim that the Massachusetts ban is preempted by federal law because “Congress required FDA to protect the public health by making sure that drugs are safe and effective,” and the Massachusetts ban conflicted with this Congressional intent by substituting Massachusetts’s determination about Zohydro’s safety and effectiveness for FDA’s.

Judge Zobel also distinguished this case from Wyeth v. Levine—the 2009 decision in which the Supreme Court held that state law failure-to-warn claims against innovator* drug companies are not preempted by federal drug labeling laws and regulations.  In that case, a patient whose hand and forearm were amputated after an IV push of Phenergan caused gangrene, sued Phenergan’s sponsor, Wyeth, for failing to adequately warn about the risks of IV-push administration.   The Court concluded that, although FDA had approved the label for Phenergan, the patient’s failure-to-warn claims were not preempted because Wyeth could have strengthened the warnings without FDA’s prior approval (through the submission of what is known as a changes-being-effected supplement), and, more relevant to the Zohydro litigation, allowing state law failure-to-warn claims did not interfere with the consumer protection purpose of the Federal Food, Drug, and Cosmetic Act.  Judge Zobel concluded that the Massachusetts ban, on the other hand, obstructed the purpose of the Federal Food, Drug, and Cosmetic Act by replacing FDA’s assessment of a drug’s safety and effectiveness with a state’s assessment, undermining FDA’s ability to promote the public health through access to safe and effective drugs.  Judge Zobel also noted that Zogenix could not comply with what Massachusetts was asking for – an abuse-deterrent formulation – without going back to FDA for approval of a different drug product.

I think Judge Zobel’s order was unquestionably the right decision from a public health perspective. Even if you think the Zohydro approval was a bad one (and I don’t necessarily think it was, for reasons I partially explain in our April podcast), there are other ways to make that case to FDA.  More importantly, the Massachusetts ban would establish a problematic precedent.  A patchwork of different requirements for drugs across the country, made by states that lack FDA’s scientific expertise, wouldn’t be good for patients or for encouraging the development of innovative new drugs.  In addition, I also think Judge Zobel made a persuasive argument for this being the right decision from a legal perspective.  Viewed broadly, the Massachusetts ban does undermine FDA’s role as our medical product gatekeeper, and there seems to be good reason to distinguish the Zohydro case from Wyeth v. Levine.


* Judge Zobel’s order did not address the other two major, recent Supreme Court decisions concerning drug labeling and preemption—Pliva v. Mensing and Mutual Pharmaceutical v. Bartlett.  Those decisions, however, concerned generic rather than innovator drug labeling.