Posts Tagged ‘pharmaceuticals’

Nevada bill: let patients sue docs, drugmakers over addiction

“A bill that would allow patients addicted to prescription drugs to sue the doctors who prescribed the medication — and the drug’s makers — was met with stiff opposition Wednesday in a Nevada legislative hearing.” Sen. Tick Segerblom (D-Las Vegas), who introduced SB 75, defended the measure: “They know the person can get addicted to the drug so they should pay for the process of them getting off it.” [AP; related effort to use drug-dealer-liability laws] (& White Coat)

Tales of competition through regulation III: pharma v. compounding pharmacies

Compounding pharmacies, which mix medications to order, are a corner of the drug business that has been much less heavily regulated than mass-manufacturing drug companies. As a result, the compounders began expanding their market presence as against the mass manufacturers, and even get into mass manufacturing methods themselves. The process accelerated in the past few years after tightened FDA control of conventional makers’ production practices (under GMP, or Good Manufacturing Practice, regulation) began to result in widespread production-line suspensions; for hospitals and other users, the availability of compounded alternatives is often the only fallback in the face of shortages.

Unfortunately, poor quality control at some compounders resulted in a series of fiascos culminating in a meningitis outbreak. Now the Washington Post reports that major drug companies are seizing the chance to hobble their competition by pressing for maximally burdensome regulation of compounders, including the addition of regulations unrelated to safety, such as rules aimed at restricting the compounding of formulas that imitate the action of patented products. Hospitals, which sometimes engage in compounding themselves to obtain medication for their patients, say overregulation could worsen the problem of drug shortages. [Kimberly Kindy and Lena Sun, Washington Post] Earlier on drug shortages here, here, etc.

Medical roundup

  • “On Average, Physicians Spend Nearly 11 Percent Of Their 40-Year Careers With An Open, Unresolved Malpractice Claim” [Health Affairs via Pauline Chen, NY Times]
  • SCOTUS lets stand Feds’ “accept Medicare or lose your Social Security” edict [Ilya Shapiro, Cato]
  • Robot surgery: from the Google ads, you might think lawyers are circling [Climateer via Tyler Cowen]
  • New York mandates more aggressive anti-sepsis measures in hospitals, and White Coat thinks it won’t end well [EP Monthly]
  • Shortages of generic FDA-regulated sterile injectables begin to take deadly toll [AP/Worcester Telegram, earlier]
  • Continuing the discussion of electronic medical records from a few days back: as medico-legal documents, EMRs are under pressure to be something other than candid and spontaneous [Kaus] While other patients wait for critical care, ER docs and nurses enter mandatory data fields for whether the infant is a smoker or the flu victim is a fall risk [White Coat]
  • Obamacare part-time-work fiasco “only starting to become news when it hits university professors” [Coyote, David Henderson, earlier]

Product liability roundup

Mayor Bloomberg vs. painkillers

“So we now have a politician directly dictating medical policy to doctors at city hospitals.” [Radley Balko]

P.S. In the mayor’s view, just as you can’t make an omelet without breaking eggs, so you can’t fight painkiller abuse without overriding doctors’ judgment: “so you didn’t get enough painkillers and you did have to suffer a little bit…. there’s nothing perfect.” [Colin Campbell, Politicker]

Medical roundup

  • “Blaming doctors for prescription drug abuse” [White Coat] Judge rules victim of pharmacy robbery can proceed with suit against doctor who prescribed painkillers [NYLJ]
  • Louisiana Gov. Jindal’s proposal for letting contraceptives be sold over counter has good libertarian pedigree [David Henderson, Jonathan Adler] More: Ramesh Ponnuru.
  • FDA vs. antiemetics: “How Long Before Zofran Gets Black Boxed?” [White Coat]
  • ObamaCare vulnerable to an Origination Clause challenge? [Sandefur vs. Taranto, via Randy Barnett]
  • “When a child drinks cologne, by all means, sue the doctor… ” [NJLRA]
  • U.S. v. Caronia: does First Amendment protect promotion of off-label drug use? [Richard Epstein/Hoover, PoL, WSJ Law Blog, D&DL, Shackford]
  • Ideas from John Goodman on med-mal reform [Psychology Today]

Medical and pharmaceutical roundup

Pharmaceutical roundup

  • False medical reports lead to echo-mill conviction [Drug and Device Law]
  • Leads for sale in mass tort cases: Actos $450, Yaz $400, Yazmin $400, Ocella $425 [Ron Miller]
  • Ninth Circuit: securities suit vs. pharmaceutical company can’t piggyback on allegations of flawed clinical trials [The Recorder]
  • Dubious management idea: subordinate policy/legislative advocacy to corporate social responsibility (CSR) department [Susan Crowley/PharmExec]
  • “Former Glaxo VP: ‘The Criminalization of the Practice of Law Is Here’” [WSJ interview with Lauren Stevens]
  • Given the state’s legal climate, does it really make sense for a big pharmco to retain its headquarters in Pennsylvania? [Ted Frank] Sounds rather appetizing actually: defendant J&J said to have run into Louisiana home cooking [Eric Alexander, D&D Law]
  • On the life-threatening shortages of sterile injectables [earlier here, etc.] here’s the official line of Margaret Hamburg’s FDA, as dutifully transcribed by the Times: if “nearly a third of the industry’s manufacturing capacity is off line because of quality issues,” it’s because that capacity had been operating in an recklessly unsafe manner, and it in no way reflects on the FDA’s stringent new GMP regulations on manufacturing processes, with which drug makers could easily comply were they not so inured to putting up with weevils, rust and urine on the production line. Note however this significant bit: “The shutdowns have contributed to a shortage of critical drugs, and [loosely state-regulated] compounding pharmacies have stepped into the gap as medical professionals scramble for alternative sources. But several serious health scares have been traced to compounding pharmacies in recent years,” including a deadly new meningitis outbreak. [Katie Thomas, NYT]

Pharmaceutical roundup

  • “In light of drug safety concerns, the FDA has made it difficult for companies to get new antibiotics approved.” Might this possibly tie in with the article’s theme that the economics of antibiotic research has turned sharply unfavorable despite a dire perceived need for new compounds? [WaPo; background, Avik Roy, Forbes; Josh Bloom, NY Post, on the coming gonorrhea epidemic]
  • Congress considers restoring asthma inhaler access [Angela Logomasini/CEI, earlier]
  • Righteous Derek Lowe rant on pharmaceutical innovation [vs. British Medical Journal; Pipeline/Corante]
  • Things the New York Times left out of its FDA spygate coverage [Jon Entine, Forbes]
  • Bill signed by President last month includes provisions attempting to address drug manufacturing shortages [Abnormal Use, earlier] Lawsuit against drug maker for withdrawing drug from market fails [Beck, Drug and Device Law]
  • Regulation-by-litigation striking out in drug pricing cases? [Cruz-Alvarez & Sherr, WLF]
  • The Seroquel black box warns of what, exactly, now? [White Coat]