Opinion Headlines

  1. FDA, sunscreen, LTE:  “Shining Light on the FDA’s Slow Approach to Sunscreen”   8-11-14
  2. FDA. “An $8.3 Billion Rebuke to the FDA” [Roche buys a drug approved in Europe but not…] 8-28-14
  3. FDA. “Your Phone Isn’t as Smart as It Could Be.” By Scott Gottlieb, et.al., [possible  health…apps..] 8-7-14
  4. FDA. LTE. “Let Competent Patients Decide, but Who’s Competent?”  8-1-14
  5. FDA. “The Right-to-Try Revolt.” [Terminally ill patients are fed up with slow FDA drug approvals.] 2-10-15
  6. FDA. “Snoopy Is Safe After All.” [Rest easy, beagles. Another chemical scare looks like a false alarm.] 2-12-15
  7. FDA. LTE. “We Knew Obama Would Propose Drug Price Controls.” 2-12-15
  8. FDA. “Washington’s Skin Cancer Hostages.” [The FDA is defying Congress and Obama on better sunscreens.] 3-14-15
  9. FDA. “Wanted: Guidelines for Access to Experimental Drugs.” By Kenneth I. Moch. [Critically ill patients need new medicines, but what if this slows FDA approval for future patients.?] 3-17-15
  10. FDA. “A Legal Cure For the FDA’s Free Speech Malady.” By David B. Rivkin Jr. et.al. [A drug maker sues the regulator for banning discussion of potential benefits from off-label use.] 5-22-15
  11. FDA. “Is the FDA Sexist?” [No, but now women know how terminal cancer patients feel.] 6-17-15
  12. FDA. “How to End the Regulatory Slowdown for New Antibiotics.” By Johathan Leff and Allan Coukell. [With the threat from lethal drug-resistant bacteria growing, the FDA needs to speed up its approval process.] 7-3-15
  13. FDA. “Trans Fats Transphobia.” [Government flips over the additive it once promoted.] 7-6-15
  14. FDA. “Government by the Pizza Slice.” [The feds say they need another year to dictate useless calorie counts.] 7-13-15
  15. FDA. “A Free-Speech Clinic for the FDA.” [A judge says companies can tell the truth about off-label drug uses.] 8-15-15
  16. FDA. Bookreview: Bookshelf by Paul Howard. “Hail Mary Medicine.” [“The Right to Try,” by Darcy Olsen.] [Patients spend their last days pleading with reluctant drug companies and the FDA to get access to treatments that could save their lives.] 11-13-15
  17. FDA. LTE. FDA Is Trying to Save Lives Via Safe, Effective Drugs. 12-15-15
  18. FDA. Medicine. “The U.S. Is Botching the Zika Fight.” By John J. Cohrssen and Henry I. Miller. [A genetically tweaked mosquito could stop the illness, but regulators won’t test it. Why would that be?] 3-14-16
  19. FDA. “The FDA vs. Austin Leclaire.” [The agency sits on a new treatment of a deadly muscular disease.] 4-22-16
  20. FDA. “Mental Dystophy at the FDA.” [How the bureaucracy denies a new drug for a deadly disease.] 4-29-16
  21. FDA. LTE. “Labeling GMO Foods Excites a Controversy.” 5-6-16
  22. FDA. “The FDA’s Vaporous Thinking About E-Cigs.” By Michael B. Siegel. [The new rules won’t benefit public health and will force thousands of small businesses to shut down.] 5-6-16
  23. FDA. LTE. “The FDA is Obtuse About Rare-Illness Drug.” 5-7-16
  24. FDA. “A Legal Test for the FDA.” [Black letter law dictates approval for a muscular dystrophy drug.] 5-10-16
  25. FDA. LTE. “FDA Must Act for Biosimilar Price Competition to Work.”  6-13-16
  26. FDA. “Please Don’t Take Away My Autistic Son’s Treatment.” By Paul E. Peterson.  [The FDA might ban the harmless skin shocks that keep him from self-injury, though they have worked.]  6-24-16
  27. FDA. “Where’s the Drug, FDA?”  [The agency keeps delaying a therapy for muscular dystrophy.]  7-2-16
  28. FDA. “Boys Not Statistics.”  [A drug for muscular dystrophy works better than we reported.]  7-8-16
  29. FDA. “Heart of Bureaucratic Darkness.”  [Why won’t the FDA make a decision on a muscular dystrophy drug?]  8-10-16
  30. FDA. “The FDA’s Misguided Nicotine Crusade.”  By Holman W. Jenkins Jr. [Why is the agency trying to ban companies that have no role in smoking-related health problems?]  8-13-16
  31. FDA. “How Obama’s FDA Keeps Generic Drugs Off the Market.” By Scott Gottlieb. [A flurry of new regulations is raising production costs and reducing competition for branded drugs.] 8-20-16
  32. FDA. “The Boys Who Beat the FDA.”  [The agency approves a drug after an ugly bureaucratic brawl.]  9-20-16
  33. FDA. “A Drug Cartel at the FDA.”  [A new rule will produce a lawsuit rush and raise prices for generics.]  9-27-16
  34. FDA. “Soldiers Can Shoot, Not Smoke.”  [An FDA ban on cigar donations to troops was no mistake.]  10-21-16
  35. FDA. “A Trumpian Cure for the FDA’s Chronic Lethargy.”  By Joseph V. Gulfo.  [Speed drug approval by getting the FDA to rate for safety and efficacy, instead of long-term outcome.]  11-22-16
  36. FDA. “Congress Cures Breakthrough.”  [Modest progress toward bringing the FDA into the 21st century.]  12-7-16
  37. FDA. “The FDA Empire Strikes Back.”  [The bureaucracy is talking down a drug the agency approved.]  12-23-16
  38. FDA. “The Burial of Ebola.”  [A vaccine for the virus, after too many deaths and bureaucratic apathy.]  12-27-16
  39. FDA. “The FDA’s Rigged Drug Committee.”  [A case study in how the agency gets the advice it wants to hear.]  1-3-17
  40. FDA. “How Trump Can Help Millions Hear.”  By Temma Ehrenfeld.  1-12-17
  41. FDA. “A National Right to Life.” [A proposal to help terminal patients past the FDA blockade.] 2-27-17
  42. FDA. [A Doctor to Heal the FDA.] [Scott Gottlieb may be Trump’s most important nominee.] 3-13-17
  43. FDA. “On ‘Right to Try,’ the FDA Should Proceed With Caution.” By Henry I. Miller. [More access to unapproved drug could be good policy, but there are risks even to terminal patients.] 3-14-17
  44. FDA, “The FDA Can Declare War on Alzheimer’s” by George Vradenburg and Howard Fillit. [Flexible standards for drug approval would help patients.] 4-5-17
  45. FDA. “The Man Who Knows Too Much.” [Democrats fret that Scott Gottlieb is too expert for the FDA.] 4-6-17
  46. FDA. “How FDA Rules Made a $15 Drub Cost $400. [ For many older medicines, government forces the original, name-brand version off the market.] 4-6-17
  47. FDA. “The FDA’s Pizza Minders.” [Your government at work: the pepperoni calorie-count rule.] 4-17-17
  48. FDA. “The Menu Label Cops Win.” [How many calories are tin a pizza slice?  The FDA demands to know.]  11-14-17
  49. FDA.  “A Dose of Accountability for the FDA.”  [The public deserves to know more when the agency kills a new drug.]  1-22-18
  50. FDA. “Medical Miracles From FDA Inefficiency.” (The Weekend Interview with David Ridley by Allysia Finley) [The economist behind the ‘priority review voucher,’ which advances treatments for neglected diseases.] 1-27-18
  51. FDA. “Giving Patients One More Shot.” [The House keeps sitting on ‘right to try” legislation.] 2-5-18
  52. FDA. “Cures Welcome at FDA” [The agency opens its thinking on Alzheimer’s to innovative methods.] 3-12-18
  53. FDA. “The Twisted Case of the ‘Deceptive’ Pretzels.” By Sheldon Bradshaw and Marisa Maleck. [How FDA ‘guidance’ letters feed meritless lawsuits against food and beverage makers.] 4-2-18
  54. FDA. “Vapin’ in the Boy’s Room.” By Sally Satel. [The moral panic over teens and e-cigarettes is clouding judgment.] 5-16-18
  55. FDA. “More Competition for Pharma.” [The FDA calls out companies that duck the law on generics.] 5-19-18
  56. FDA. “A Risky Drug Approval Lesson” [What the FDA can learn from progress against muscular dystrophy.] 7-5-18
  57. FDA.  “The Organic Industry is Lying to You.”  By Henry Miller. [Normally a strict regulator, the FDA gives advertisers a complete pass.]  8-6-18
  58. FDA.  “A Shot of Competition for EpiPen.”  [the FDA removes a barrier to approval of ‘complex generis.’]  8-20-18
  59. FDA.  “Follow the FDA’s Self-Interest.”  By Henry I. Miller.  [While approving a new form of insulin, I saw how regulators protect themselves.]  10-29-18
  60. FDA.  “The FDA Was Wise to Approve a New Opioid.”  By Sally Satel.  [The use of Dsuvia is limited, and wounded soldiers need it.]  11-8-18
  61. FDA.  “More Lawsuits = Higher Drug Prices.”  [The FDA pulls an Obama rule that was a trial-lawyer special.]  12-19-18
  62. FDA.  “Fighting a Tort Plague.”  [Should a drug company be punished for following FDA rules?]  1-7-19
  63. FDA.  “The FDA’s Challenge On E-Cigs.”  By Scott Gottlieb.  [Minimize the danger to minors while preserving a smoking-cessation tool.]  6-25-19
  64. FDA.  “Marijuana Activists Pass Their High Point.”  By Alex Berenson.  [They thought 2019 would be a year of nationwide triumph.  Instead, the backlash has begun.]  6-26-19
  65.  Marijuana.  “Why I Won’t Support Legalizing Hemp.”  by Kristi Noem.  [Until the law can tell the difference between it and weed, the answer is ‘no.’] 9-10-19
  66. FDA. ”Thank You for Not Vaping.” 1-3-20
  67. FDA. “FDA Shouldn’t Keep Safe Drugs off the Market. By Charles L. Booper and David R. Henderson. [Congress’s mandate that medications be proved effective is unnecessary and delays potential cures.] 3-26-20
  68. FDA.  “The FDA’s Good Plasma Decision.”  [Ignore Trump’s tweet.  This is the right decision based on the science.]   8-25-20
  69. FDA.  “You Can Trust the FDA’s Vaccine Process.”  By Scott Gottlieb and Mark McClellan.  [The agency can roll out a Covid shot safely, quickly and without bowing to political pressure.]   9-21-20
  70. FDA.  “The FDA’s Political Inoculation.”  [Thy the U.K. has approved a vaccine faster than the U.S.]   12-4-20
  71. FDA.  “Liberation Day for French Dressing.”  [The FDA also eases its vigilance over cherry pie standards.]   12-28-20
  72. FDA.  “The Battle Over an Alzheimer’s Treatment.”  [Biogen’s promising drug is caught in the FDA’s bureaucratic limbo.]   4-20-21
  73. FDA.  “A Slow FDA Is Denying ALS Patients Their Only Hope.”  [An archaic regulatory process that depends on placebo trials is blocking access to new drugs.]   4-27-21
  74. FDA.  “Risk Management and the Formula Crisis.”  By Phillip S. Coles.  [The FDA should have had preapproved alternative suppliers as part of a supply-chain strategy.]   5-19-22
  75. FDA.   “Why Wont the FDA Let Doctors prescribe Fluvoxamine for Covid?”  by Allysia Finley.  [Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use.]   5-31-22
  76. FDA.  “The FDA’s Anti-Nicotine Myopia.”  By Holman W. Jenkins, jr.  [Legal parsing plus ideology has the agency reenacting the folly of Prohibition.]   7-6-22
  77. FDA.  “The FDA Misses Its Hit on Juul.”  [After it was sued, the agency admits that it ignored key evidence.]   7-8-22
  78. FDA.  “A Biden Hearing-Aid Breakthrough.”  [A new FDA rule will allow more competition and reduce prices.]  8-17-22
  79. FDA.  “The FDA and an ALS Treatment.”  [A new drug offers rare hope for patients if the agency approves it.]   9-13-22
  80. FDA.  “The Zantac Scare and Junk Science.”  [A federal judge exposes the false claims behind a trial-lawyer assault.]  12-9-22
  81. FDA.  “The U.S. Department of Masara.”  [The omnibus bill gives the FDA new power to police the beauty aisle.]   12-21-23
  82. FDA.  “The FDA Returns to Its Bad Habits.”  [The agency may nix a new treatment for an orphan disease.]   2-21-23
  83. FDA.  “How the FDA Helped Fuel the Opioid Epidemic.”  By Charles L. Hooper.  [Bureaucratic error caused the failure of a promising nonaddictive painkiller.  Can it be corrected?]   5-3-23
  84. FDA.  “FDA Commissioner Gets Political.”  [Robert Califf’s job is safety and efficacy, not drug prices.]   6-12-23
  85. FDA.  “DayQuil, Covid Vaccine Boosters and FDA Science.”  By Allysia Finley.  [The industry studies that showed a decongestant was effective turned out to be flawed.  Sound familiar?]   9-18-23
  86. FDA.   “The FDA’s See-No-Data Approach.”  By Stephen Cederbaum  and Emil Kakkis.  [“…Discovering treatments for rare diseases is a daunting task…”]   9-27-23
  87. FDA.  “The FDA’s Laboratory Land Grab.”  [The agency wants to treat academic lab tests like medical devices.]  10-11-23
  88. FDA.  “Requiem for an Alzheimer’s Drug.”   2-1-24
  89. FDA.  “The FDA Could Help Save My Son from a Rare Disease.”  By Judy Stecker.  [Instead, the agency keeps safe treatment out of the hands of patients with no tother options.]   2-28-24
  90. FDA.  “Requiem for a Drug Maker.”  [After 24 years In business, an innovator hit the FDA’s roadblock.]   4-8-24

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