Search Results for ‘"off-label"’

Don’t deprecate off-label drug prescribing

Is it questionable and suspicious for doctors to administer a medication that has not been proved effective for the use in question? Nope. It’s perfectly normal. I explain “off-label prescribing” in a new opinion piece at the Washington Examiner, the news hook being the recent flap about chloroquine/hydroxychloroquine as possible treatments for COVID-19. A related Twitter thread is here as well as here, and here’s our earlier coverage of off-label prescribing.

Also related, this recent line from Scott Alexander is so apt: “Just like the legal term for ‘not proven guilty beyond a reasonable doubt’ is ‘not guilty’, the medical communication term for ‘not proven effective beyond a reasonable doubt’ is ‘not effective'”.

May 21 at AEI: Off-Label Uses of Approved Drugs: Medicine, Law, and Policy

An important all-day conference at AEI next week:

In the last several years, nearly every major pharmaceutical company has paid hundreds of millions of dollars to settle allegations of illegal “off-label” marketing of drugs. There has been a growing trend of actions by federal prosecutors, state attorneys general, and cooperating trial lawyers to litigate against pharmaceutical manufacturers for allegedly doing too much to promote off-label use of prescription products. Citing recent legal changes mandating exclusion from federal programs after a conviction, many manufacturers say they are forced to settle rather than risk defending themselves–even as prosecutions against individual executives have foundered in front of juries.

At this AEI Legal Center event, experts on both law and health care will present papers on the law, economics, medicine, and public policy of off-label marketing, discussing everything from the abuse of class action mechanisms to implications for the First Amendment and medical malpractice. Speakers include former Food and Drug Administration chief counsel Daniel Troy; former Cephalon general counsel John Osborn; former deputy attorney general George Terwilliger; principal deputy assistant attorney general and acting assistant attorney general for the Civil Division Jeffrey Bucholtz; attorneys Brian Anderson, James Beck, Mark Herrmann, Richard Samp, and Kyle Sampson; law professor Margaret Johns; and AEI scholars John E. Calfee, Theodore H. Frank, and Scott Gottlieb.

Panel I: Off-Label Marketing, R&D, and Medical Practice

Panel II: The Legal Environment from Federal Regulation and Enforcement

Panel III: Distortions from State and Private Enforcement

Panel IV: Legal Implications for Commercial Speech and Medical Practice

Register here. Earlier discussion on POL: Feb. 1; Feb. 19; Mar. 24; Dec. 17; Aug. 31; Aug. 22 (Richard Epstein); Aug. 1, 2006 (state AGs); Mar. 19 (InterMune indictment).

Pharmaceutical and medical device roundup

  • “Feds Say It’ll Take Up To 90 Days to Approve New Mask-Making Facilities” [Christian Britschgi, Reason] “America Could Import Countless More Face Masks if Federal Regulators Would Get Out of the Way” [Eric Boehm] Reversing course, FDA agrees to permit wider use of a system developed by Battelle for sterilizing specialized masks worn by front-line health workers [Rachel Roubein, Politico] In the face of mounting criticism, federal Centers for Disease Control may reconsider guidance discouraging general public from wearing face masks [Joel Achenbach, Washington Post]
  • What would we do without the FDA? “FDA Tells At-Home Diagnostics Companies To Stop Coronavirus Test Roll-Outs; The companies are complying. Customers won’t get their results and are being told to destroy their test kits.” [Ronald Bailey, Reason] Small favors: FDA “is easing up on some regulations so that ventilators can be manufactured and implemented more quickly” to respond to crisis [Scott Shackford]
  • And the same continued: “The idea to expand testing of drugs and other medical therapies was strongly opposed by the FDA’s senior scientists this week, the official said, and represented the most notable conflict between the FDA and the White House in recent memory.” [Tyler Cowen] “FDA Shouldn’t Keep Safe Drugs off the Market” [David Henderson]
  • Off-label or no, “the FDA granted an emergency authorization request to make chloroquine and hydroxychloroquine available from the Strategic National Stockpile (SNS), the federally operated supply of medical equipment and pharmaceuticals for use in public health emergencies.” [Naomi Lopez and Christina Sandefur, In Defense of Liberty (Goldwater Institute); Ronald Bailey; Jim Beck; earlier on off-label prescribing here, etc.] Switch of beverage alcohol firms to making hand sanitizer was advanced by waivers from FDA and Alcohol and Tobacco Tax and Trade Bureau [Jeffrey Miron and Erin Partin]
  • Needless face-to-face consults avoided: “Health Canada Sets A Good Example By Relaxing Opioid Prescribing Rules During COVID-19 Pandemic” [Jeffrey Singer, Cato] Some moves in the right direction in the U.S. too [Singer]
  • Even the New Jersey courts aren’t buying the ambitious theory of “fourth-party payor liability,” in which a plaintiff who never “claimed to have used the product, paid for the product, acquired the product, or had any interaction with the product (or its alleged manufacturers) in any way” nonetheless sues them for supposedly driving up health insurance costs [James Beck, Drug & Device Law]
  • Heartburn drug: “Trial lawyers start search for next big mass tort, increase Zantac ads by more than 1,000%” [John O’Brien, Chamber-backed Legal Newsline]

Medical roundup

  • “Doctors as Data Entry Clerks for the Government Health Surveillance System” [Jeffrey Singer, Cato]
  • “Judge Orders Spine Surgeon to Pay Discovery Fees Over Funding Model” [Greg Land, Daily Report Online (Atlanta); defense lawyer says case “throws a harsh light on the interaction between personal injury lawyers, healthcare providers and litigation funders”]
  • What if feds’ enforcement policies on truthful off-label pharmaceutical promotion run aground on First Amendment considerations? [James Beck, Drug and Device Law]
  • Chronic pain patients: “Civilian Casualties Continue to Mount in Governments’ War on Opioids” [Jeffrey Singer] Feds’ tightening of opioid scheduling cut refills, but increased number of pills initially prescribed [same] So sinister for psychiatrist to take cash payment and keep night hours in a rented office, or is it? [Ira Stoll]
  • Certificate-of-need laws: “North Carolina Doctor Sues to Break Up State-Enforced Medical Cartels” [Christian Britschgi, Reason]
  • Law firm of Morgan & Morgan, awarded contingency contract for Kentucky opioid suit, holds fundraiser for Kentucky AG Andy Beshear [Legal NewsLine]

Pharmaceutical roundup

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.

Medical roundup

Liability roundup

  • Hoping to blame Pacific Gas & Electric power lines for Northern California fires, lawyers from coast to coast descend on wine country [Paul Payne, Santa Rosa Press-Democrat]
  • Courts should police lawyers’ handling of class actions, including temptation to sweep additional members with doubtful claims into class so as to boost fees [Ilya Shapiro, Trevor Burrus, and Reilly Stephens on Cato certiorari amicus in case of Yang v. Wortman]
  • “Seventh Circuit Curtails RICO Application to Third-Party Payor Off-Label Suits” [Stephen McConnell, D&DL] “Here Is Why The False Claims Act Is An ‘Awkward Vehicle’ In Pharma Cases” [Steven Boranian]
  • Litigation finance moves into car crash business [Denise Johnson, Insurance Journal]
  • Slain NYC sanitation worker’s “frequent advice to Sanitation colleagues about how to save for the future helped persuade the jury that Frosch had a viable career ahead of him in financial planning,” contributing large future earnings component to $41 million award [Stephen Rex Brown, New York Daily News]
  • “Ninth Circuit Overturns State Licensing Scheme Forcing Businesses to Incorporate in California” [Cory Andrews, WLF]

Tales of discovery: document request in qui tam case

And speaking of discovery, reader W.C. writes to say:

This is a False Claims Act case. I am not terribly interested in the substance (relators claim that a drug was recommended for off-label use and that Medicaid shouldn’t have paid for it; they complained and were fired).

What is interesting is taxable costs. Fifth Circuit affirmed (finding no abuse of discretion for an award of) $232,809.92.

Money quotes for me: “The district court acknowledged that [Defendant]’s invoices were not detailed but explained that, given nearly three million pages of copies [Defendant] produced for its defense in this case, it would have been impossible for [Defendant] to explain each page’s usefulness.” (emphasis added). The Court also allowed for “costs relating to (1) TIFF image conversion, (2) scanning, (3) formatting electronic documents, and (4) PDF conversion – per [28 U.S.C.] § 1920(4), which allows recovery for ‘exemplification’ and ‘making copies’ of case materials,” and confirmed that the district “allow[s] a prevailing party to recover the costs of complying with an opposing party’s request to reformat electronic documents or scan hard copies of documents” under 28 USDC s 1920.

Lessons: (i) You might want to more narrowly tailor those discovery request; (ii) Defendants had asked for $961,380.52, so maybe the back up the truck strategy was not 100% effective.

Medical roundup

  • Bill advancing in California legislature would authorize jail for nursing home staff who “willfully and repeatedly fail to use a resident’s preferred name or pronouns” [Eugene Volokh, SB 219]
  • “The FDA cannot get out of its own way on the issue of off-label communications.” [Stephen McConnell, Drug and Device Law Blog first and second posts]
  • Public health covets territory of other studies and disciplines, part CLXXII [British Medical Journal on American College of Physicians’ resolution declaring “hate crimes” and “legislation with discriminatory intent” to be public health issues]
  • Podcast on battle between Vascular Solutions and the FDA [Federalist Society with Howard Root and Devon Westhill]
  • Policy U-turns needed: “Deregulation and Market Forces Can Lower Pharmaceutical Prices” [Marc Joffe, Reason]
  • Florida Supreme Court ignored market history in striking down noneconomic damages limits in medical malpractice awards [Robert E. White, Jr., Insurance Journal and Andrew S. Bolin, WLF on North Broward Hospital District, et al v. Kalitan]