Posts Tagged ‘FDA’

After outbreak of bootleg-vape injuries, government restricts aboveboard vaping products

1) Batches of black-market vaping products, mostly containing THC rather than nicotine and used to get high, turn out to contain adulterants, most likely Vitamin E acetate, known to be harmful when inhaled. Over a period of weeks, hundreds of users fall seriously ill and several die in a classic “bad batch” episode familiar to epidemiologists and those who study the Drug War. [Erin Schumaker, ABC News]

2) Government reacts by banning a range of lawful nicotine vaping products sold in stores, none of which have been implicated in the deaths or injuries.

3) Predictable result: to drive some nicotine vape users back to cigarette smoking, and others toward sources of black-market supply. Good job, government! What problem would you like to fix next?

[Kimberly Leonard and Cassidy Morrison, Washington Examiner; Federalist Society Regulatory Transparency Project video featuring Sally Satel; Slate podcast with Jacob Grier; Jeffrey Singer, New York Daily News]

More: “Might restricting e-cigarette flavors actually increase smoking? (And acculturate vapers to tobacco flavors?) There’s actually some research on that” [Jonathan Adler on Twitter] Plus: trial lawyers circle vaping industry [Brendan Pierson, Reuters]

Filed under: FDA, illegal drugs, nanny state, tobacco

Pharmaceutical roundup

Starting in mid-1990s German doctors began writing many more opioid prescriptions. But addiction and overdose rates did not skyrocket. What made Germany different? [Jeffrey Singer, Cato; Jacob Sullum, Reason]
Will the Supreme Court’s unanimous ruling in Merck v. Albrecht manage to clarify preemption law? [Beck, Drug & Device Law and more; Jonah Knobler, Washington Legal Foundation]
Money didn’t go into state treasury: “Oklahoma Lawmakers not so Happy About Purdue Pharma Settlement” [Sean Murphy, Insurance Journal, more] “Nevada AG’s old law firm can make up to $350 million on his opioid lawsuit” [Daniel Fisher, Legal Newsline] “List of firms handling Louisiana’s opioid lawsuit balloons to 17, including politically connected ones” [Sam Karlin, The Advocate] Richard Epstein on opiate litigation [Ricochet]
National Vaccine Injury Compensation Program: “Where Calls for Overturning Bruesewitz v. Wyeth Go Wrong” [Dorit Reiss, Petrie-Flom “Bill of Health”]
“Drug lawsuit ads are scaring seniors to death” [P. Roosevelt Gilliam III and Susan Peschin, STAT]
Senate Republicans file bill to fast-track FDA consideration of over-the-counter birth control pill [Elizabeth Nolan Brown]

Filed under: FDA, Germany, Louisiana, Nevada, Oklahoma, opioids, pharmaceuticals, preemption, Supreme Court

Medical roundup

“How the Reformulation of OxyContin Ignited the Heroin Epidemic” [William N. Evans and Ethan Lieber, Cato Research Briefs in Economic Policy] Antiquated regulations on methadone need revision [Jeffrey Singer, Cato] Concept of addiction is constantly run together with that of dependence, and applied in such dubious areas as “social media addiction” [Singer]
EEOC sues Tennessee hospital over lapse of religious accommodation in its mandatory flu shot policy (but is a mask as effective as the vaccine?) [EEOC press release]
Free to Choose Medicine: a review [Thomas Hemphill, Cato Regulation magazine]
Texas law limiting med-mal suits: “Fifteenth Anniversary of Proposition 12” [Texans Against Lawsuit Abuse]
Time to include electronic components in the BAAA: “Biomaterials Access for the 21st Century” [Jim Beck]
Affordable Care Act’s incentive program punishing hospitals for readmissions had unintended consequences, we know now. Were some of them lethal? [Tyler Cowen on Rishi K. Wadhera, Karen E. Joynt Maddox and Robert W. Yeh, New York Times]

Filed under: EEOC, FDA, hospitals, medical malpractice, ObamaCare, opioids, Texas, vaccines

December 12 roundup

“Scott Gottlieb’s FDA Is Moving Toward a Stealth Ban on Cigarettes and Cigars” [Jacob Grier, Reason]
Supreme Court should take Melissa and Aaron Klein cake-refusal case from Oregon and resolve the issues of free expression it dodged in Masterpiece [Ilya Shapiro and Patrick Moran, ABA Journal, earlier on Melissa and Aaron Klein cake-refusal case including oppressive $135,000 fine levied by Oregon BOLI (Bureau of Labor and Industries)]
“Administrative Law Is Bunk. We Need a Bundesverwaltungsgericht” [Michael Greve, responses from Mike Rappaport, Philip Wallach, and Ilan Wurman, and rejoinder from Greve]
New York’s family court system is failing children and their families [Naomi Riley/City Journal, thanks for quote]
“The Emmys People Are Opposing A Pet Products Company Named After A Dog Named ‘Emmy'” [Tim Geigner, TechDirt]
Metaphor alert: “Lawmaker Injured by Flying Constitution” [Kevin Underhill, Lowering the Bar, and funny throughout]

Filed under: administrative law, constitutional law, family law, FDA, tobacco

“How One Company Got the FDA to Ban All Its Competitors”

Via columnist John Kelly at the Washington Post, the story of an all-but-forgotten circa-1980 scandal at the FDA over contact lens cleaning solutions [David Boaz, Cato]

Filed under: competition through regulation, FDA

Medical roundup

“Researchers from Duke and MIT… found that the possibility of a lawsuit increased the intensity of health care that patients received in the hospital by about 5 percent — and that those patients who got the extra care were no better off.” [Margot Sanger-Katz, New York Times]
Cato Policy Analysis and podcasts (with Caleb Brown) by Terence Kealey: “The Feds’ Demonization of Dietary Fat” and “Why Does the Federal Government Issue Damaging Dietary Guidelines?” Related: Britain’s “food supply is being taxed, regulated and reformulated – on the pretext of a lie” [Christopher Snowdon, Spectator (U.K.)]
New Jersey, a key state because of its volume of pharmaceutical liability litigation, joins national trend by adopting Daubert standard on expert evidence [Colleen O’Dea/N.J. Spotlight, Beck, John O’Brien/Legal NewsLine]
“Criminal prosecution for violating HIPAA: an emerging threat to health care professionals” [Anne M. Murphy, Laura B. Angelini, and Jared Shwartz, STAT]
Do-it-yourself workarounds for obtaining compounds blocked or restricted by FDA/pharma regulation, albeit entangled with IP issues. With bonus code-as-speech angle [Daniel Oberhaus, Vice Motherboard]
“Hotels do want to tell you the real price. Until hospitals do too, they will find their way around disclosure regulations” [John Cochrane; related Cochrane on lack of price competition among air ambulances]

Filed under: Daubert, defensive medicine, FDA, HIPAA, hospitals, medical malpractice, New Jersey, obesity

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]

Filed under: FDA, Florida, medical, opioids, pharmaceuticals, taxis and ridesharing

Menu labeling: “Obama’s calorie rule kicks in thanks to Trump”

“An oft-forgotten provision of Obamacare is being pushed over the finish line by Trump’s FDA.” [Helena Bottemiller Evich, Politico; Jacob Sullum (FDA overstates evidence); Mike Riggs (FDA honcho Scott Gottlieb “is not a free market firebrand”); Christian Schneider, USA Today] Earlier on FDA menu labeling here.

Filed under: FDA, ObamaCare, obesity, restaurants

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”).

Filed under: administrative law, FDA, on TV and radio, petty fines and fees, regulation and its reform

Medical roundup

“Trump Joins Campaign To Force Big Pharma To Pay for Opioid Crisis” [Ira Stoll] “Records show all-out, unsolicited attorney scramble to sign up Texas counties for opioid litigation” [David Yates, Southeast Texas Record] “Plaintiff Lawyers See Nationwide Settlement As Only End For Opioid Lawsuits” [Daniel Fisher, LNL/Forbes] “Leading Opioid Litigation Firm Becomes a Top Donor to McCaskill Leading Up to Report’s Release” [Ethan Stoetzer, Inside Sources]
NYT columnist David Leonhardt pens column urging cutting back on sweets as a political gesture against “attempts to profit off your body,” and others push back [Ira Stoll; Tamar Haspel, citing this 2016 piece on how the science is more complicated]
“Study: Medical Expenses Cause Close to 4% of Personal Bankruptcies—not 60%” [Michael Cannon, Cato; earlier here, etc., related here]
Genetic engineering of animal life: “How the FDA Virtually Destroyed an Entire Sector of Biotechnology” [John Cohrssen and Henry Miller, Cato “Regulation”]
“Very cheap (tobacco) products should no longer be available.” Why should you get to decide that for other people? [John Stossel, Reason]
Lawyer ads scare patients out of taking needed medication [download Cary Silverman, U.S. Chamber Institute for Legal Reform via John O’Brien, Forbes]

Filed under: chasing clients, FDA, obesity, opioids, pharmaceuticals, Texas, tobacco