Posts Tagged ‘FDA’

Medical roundup

Medical roundup

  • Wrong on many other issues, the American Medical Association is right to resist an artificial 3-day limit on opiate prescriptions [Jeffrey Singer, Cato; Jacob Sullum]
  • “Does Ride-Sharing Substitute for Ambulances?” [Leon S. Moskatel and David J. G. Slusky, Cato Research Briefs in Economic Policy No. 114]
  • Fourth Circuit tosses Maryland law banning “price gouging” of “essential” generic drugs, finding that state violates Dormant Commerce Clause by presuming to control transactions entirely outside its boundaries [Zack Buck, Bill of Health; Stephen McConnell, Drug and Device Law]
  • President Trump signs “right to try” legislation expanding right of terminally ill patients to enter unapproved therapies; squaring this with existing FDA regulation may present knotty problems [Michael Cannon, Cato; Michael Maharrey (“In fact, victories in 40 state legislatures preceded Trump’s signing ceremony”); earlier here, here, and at Cato Unbound last year] More cautions from Jim Beck on liability angle [Drug and Device Law]
  • Florida, departing from other states’ practice, caps its outside lawyers’ recovery at $50 million: “Latest Wave Of State Opioid Lawsuits Shows Diverging Strategies And Lawyer Pay Scales” [Daniel Fisher, Forbes]
  • In medical innovation, “equality is a mediocre goal. Aim for progress.” [Tyler Cowen]

Finally, rules to rein in agency guidance documents

Agencies use informal guidance documents in lieu of formal regulation to clarify and interpret uncertainties in existing law and enforcement. Unfortunately, this and other forms of “subregulatory guidance” can also offer a tempting way to extend an agency’s power and authority into new areas, or ban private actions that hadn’t been banned before, all without going through the notice and comment process required by regulation, with its protections for regulated parties. Fair? Lawful? The Department of Justice under Jeff Sessions has lately sought to bring agency use of guidance documents under better control, and in particular end the use of documents that 1) are obsolete, 2) improperly use the process to circumvent the need for formal regulation, or 3) improperly go beyond what is provided for in existing legal authority. I’m interviewed about all this by Caleb Brown for the Cato Daily Podcast.

More: Charlie Savage, New York Times (DoJ revokes batch of guidance documents), Matt Zapotosky/Washington Post; Scott Shackford, Reason (rescission of guidance letter on local fines and fees should be read not as blessing those practices as okay, but as reflecting fact that federal government lacks clear statutory or constitutional mandate to intervene against them); Stephen McConnell, Drug and Device Law (“DOJ Says its Litigators May Not Use Noncompliance with FDA Guidances as Basis for Civil Enforcement Actions”).

Medical roundup

Medical roundup

  • Burdensome though it is in other ways, HIPAA does not create a private right of action, so no big-ticket damage suits. Connecticut high court rides to rescue by creating new tort for breach of medical confidentiality [Steven Boranian, Drug and Device Law]
  • Details of cases aside, once again, should federal law really be requiring healthcare employers to grant religious exemptions to staff unwilling to undergo flu vaccination? [Department of Justice press release on suit against Ozaukee County, Wisconsin; earlier on EEOC settlement against North Carolina hospital]
  • First Amendment should come into play when FDA bans drug providers from making truthful statements about their therapies [Henry Miller and Gregory Conko, Reason] And a Cato panel discussion on FDA regulation of speech with former Vascular Solutions CEO Howard Root (author of “Cardiac Arrest”), Christina Sandefur of the Goldwater Institute, and Jessica Flanigan of the University of Richmond, moderated by Cato’s Michael Cannon;
  • “Uberizing Nonemergency Medical Transportation” [Ann Marie Marciarille, Prawfsblawg]
  • “Protecting Reasonable Physician Choice in Medical Product Cases” [Luther Munford, Drug and Device Law]
  • Britain’s National Health Service lurches toward crisis in negligence payouts [BBC, Paul Goldsmith, Centre for Policy Studies]

Medical roundup

  • “The dominant narrative about pain treatment being a major pathway to addiction is wrong, [and] an agenda heavily weighted toward pill control is not enough.” [Sally Satel on origins of opioid crisis]
  • The press gets it wrong: “A Young Mother Died Because Her Flu Meds Were Too Expensive – Or Did She?” [Josh Bloom, ACSH]
  • New research brief: tort reform could have effects in both directions on innovation [Alberto Galasso and Hong Luo, Cato]
  • Appalling: editor of The Lancet extols Marx as a guide to understanding medical science [Theodore Dalrymple, Law and Liberty]
  • “We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket” [Stephen McConnell, Drug & Device Law Blog]
  • Should the Food and Drug Administration concern itself with the effect of its decisions on drug prices? [David Hyman and William Kovacic, Regulation mag]

Pharmaceutical roundup

PLF files legal challenge to FDA vaping rules

As I noted in this space a year and a half ago, the Food and Drug Administration’s restrictions on vaping (e-cigarette) products — which questionably apply the Tobacco Control Act to products that contain no tobacco — “will drastically restrict and maybe even ban a popular option for smokers seeking to quit the cigarette habit. It’s not just an assault on individual choice and commercial freedom — it could wind up killing people.” Along the way, the agency would dent consumer choice in the cigar market.

Now the Pacific Legal Foundation has filed a challenge to the FDA rules, with separate legal actions in three courts. PLF’s central objection is that the regulation was issued by a career FDA civil servant without proper legal authority to do so. Ilya Shapiro, Washington Examiner:

It turns out that the FDA has for many years been delegating its rulemaking authority to its “associate commissioner for policy,” a career civil-service position two rungs below FDA Commissioner in the bureaucratic depth chart. For eight years, the Associate Commissioner for Policy has been a woman by the name of Leslie Kux. It was Kux, not then-Secretary Sylvia Burwell or then-Commissioner Robert Califf, who signed and issued the Deeming Rule.

Why is this a problem? Because the Constitution draws a distinction between “Officers of the United States” and mere employees of the federal government. Only officers can exercise “significant authority” under federal law. But in exchange for that greater power, officers must go through a constitutionally prescribed procedure, typically nomination by the president and confirmation by the Senate (with a few exceptions applicable only to inferior officers). This ensures that anyone appointed to a policymaking role — one whose duties go beyond the ministerial and advisory — will first have their character and judgment vetted by the politically accountable Senate (who shares in the blame when an appointment goes wrong).

The power to issue a final rule is indisputably a “significant authority” reserved only to officers.

While FDA commissioners have purported to delegate rule issuance authority to the permanent employee, PLF argues that the Constitution does not permit them to evade its prescription by such means.

Beyond that, the rules’ restrictions on marketing — which forbid companies to promote vaping as a method of harm reduction that could benefit existing smokers, even if that statement is plainly true — run into the First Amendment and the protections it affords to much truthful commercial speech. PLF:

The vaping edict flouts the First Amendment by forcing businesses to run a daunting regulatory gauntlet in order to advertise truthful information. The government can’t require pre-approval for truthful speech, and it especially can’t shift the burden of proof to the speaker to prove the benefits of his speech will outweigh any harms the government perceives may result.

Beyond violating the Constitution, the vaping rule is horrible public policy: it threatens to shut down thousands of small businesses that provide potentially life-saving products and creates a public safety hazard by making it very difficult to improve and repair products.

Courts are no place to set opioids policy

The “American public may soon pay for a billion-dollar wealth transfer from the pharmaceutical industry to state and local government,” writes Margaret Little:

Proceedings moving apace before Ohio U.S. District Judge Dan Polster bode the worst of all solutions to the opioid crisis – a swift global settlement modelled on the tobacco settlement of the 1990s. The result will inflict lasting damage on our constitutional order and do virtually nothing to solve the opioid crisis. Opioid abusers, just like smokers in the infamous tobacco settlement, stand to receive nothing. A single unelected federal judge will have feigned to have “solved” opioids, levied billions in unlegislated taxation, made drugs more costly and harder to secure for non-abusers while leading abusers to turn to heroin and fentanyl, and filled state and local coffers with revenue-by-judiciary while richly endowing trial lawyer barons – hand-picked by the judge – with billions in public funds. A swift education of the American public about this abuse of the judicial process is in order, not a swift settlement.

More: “After New York Sues Opioid Manufacturers, Drug Policy Experts Warn That Legal Action Won’t Save Lives” [Zachary Siegel, In Justice Today] The FDA is charged with setting uniform national policy on pharmaceuticals; will it allow regulatory power to be transferred pell-mell to MDL court or to the actors in a resulting settlement? [WLF] And from Jim Beck, Drug and Device Law:

…injuries from illegal opioid use are precisely the sort of injuries that the in pari delicto doctrine was designed to preclude from being recovered in litigation.

Well, what about the states as plaintiffs?…[W]ho can restrict the rights of physicians to prescribe drugs for off-label uses? That would be the states, in their traditional roles of regulators of medical practice…. States could ban precisely the off-label uses they are complaining about, but they haven’t.

Earlier here.