Opinion Headlines
- FDA, sunscreen, LTE: “Shining Light on the FDA’s Slow Approach to Sunscreen” 8-11-14
- FDA. “An $8.3 Billion Rebuke to the FDA” [Roche buys a drug approved in Europe but not…] 8-28-14
- FDA. “Your Phone Isn’t as Smart as It Could Be.” By Scott Gottlieb, et.al., [possible health…apps..] 8-7-14
- FDA. LTE. “Let Competent Patients Decide, but Who’s Competent?” 8-1-14
- FDA. “The Right-to-Try Revolt.” [Terminally ill patients are fed up with slow FDA drug approvals.] 2-10-15
- FDA. “Snoopy Is Safe After All.” [Rest easy, beagles. Another chemical scare looks like a false alarm.] 2-12-15
- FDA. LTE. “We Knew Obama Would Propose Drug Price Controls.” 2-12-15
- FDA. “Washington’s Skin Cancer Hostages.” [The FDA is defying Congress and Obama on better sunscreens.] 3-14-15
- 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
- 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
- FDA. “Is the FDA Sexist?” [No, but now women know how terminal cancer patients feel.] 6-17-15
- 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
- FDA. “Trans Fats Transphobia.” [Government flips over the additive it once promoted.] 7-6-15
- FDA. “Government by the Pizza Slice.” [The feds say they need another year to dictate useless calorie counts.] 7-13-15
- FDA. “A Free-Speech Clinic for the FDA.” [A judge says companies can tell the truth about off-label drug uses.] 8-15-15
- 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
- FDA. LTE. FDA Is Trying to Save Lives Via Safe, Effective Drugs. 12-15-15
- 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
- FDA. “The FDA vs. Austin Leclaire.” [The agency sits on a new treatment of a deadly muscular disease.] 4-22-16
- FDA. “Mental Dystophy at the FDA.” [How the bureaucracy denies a new drug for a deadly disease.] 4-29-16
- FDA. LTE. “Labeling GMO Foods Excites a Controversy.” 5-6-16
- 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
- FDA. LTE. “The FDA is Obtuse About Rare-Illness Drug.” 5-7-16
- FDA. “A Legal Test for the FDA.” [Black letter law dictates approval for a muscular dystrophy drug.] 5-10-16
- FDA. LTE. “FDA Must Act for Biosimilar Price Competition to Work.” 6-13-16
- 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
- FDA. “Where’s the Drug, FDA?” [The agency keeps delaying a therapy for muscular dystrophy.] 7-2-16
- FDA. “Boys Not Statistics.” [A drug for muscular dystrophy works better than we reported.] 7-8-16
- FDA. “Heart of Bureaucratic Darkness.” [Why won’t the FDA make a decision on a muscular dystrophy drug?] 8-10-16
- 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
- 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
- FDA. “The Boys Who Beat the FDA.” [The agency approves a drug after an ugly bureaucratic brawl.] 9-20-16
- FDA. “A Drug Cartel at the FDA.” [A new rule will produce a lawsuit rush and raise prices for generics.] 9-27-16
- FDA. “Soldiers Can Shoot, Not Smoke.” [An FDA ban on cigar donations to troops was no mistake.] 10-21-16
- 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
- FDA. “Congress Cures Breakthrough.” [Modest progress toward bringing the FDA into the 21st century.] 12-7-16
- FDA. “The FDA Empire Strikes Back.” [The bureaucracy is talking down a drug the agency approved.] 12-23-16
- FDA. “The Burial of Ebola.” [A vaccine for the virus, after too many deaths and bureaucratic apathy.] 12-27-16
- FDA. “The FDA’s Rigged Drug Committee.” [A case study in how the agency gets the advice it wants to hear.] 1-3-17
- FDA. “How Trump Can Help Millions Hear.” By Temma Ehrenfeld. 1-12-17
- FDA. “A National Right to Life.” [A proposal to help terminal patients past the FDA blockade.] 2-27-17
- FDA. [A Doctor to Heal the FDA.] [Scott Gottlieb may be Trump’s most important nominee.] 3-13-17
- 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
- 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
- FDA. “The Man Who Knows Too Much.” [Democrats fret that Scott Gottlieb is too expert for the FDA.] 4-6-17
- 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
- FDA. “The FDA’s Pizza Minders.” [Your government at work: the pepperoni calorie-count rule.] 4-17-17
- FDA. “The Menu Label Cops Win.” [How many calories are tin a pizza slice? The FDA demands to know.] 11-14-17
- FDA. “A Dose of Accountability for the FDA.” [The public deserves to know more when the agency kills a new drug.] 1-22-18
- 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
- FDA. “Giving Patients One More Shot.” [The House keeps sitting on ‘right to try” legislation.] 2-5-18
- FDA. “Cures Welcome at FDA” [The agency opens its thinking on Alzheimer’s to innovative methods.] 3-12-18
- 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
- FDA. “Vapin’ in the Boy’s Room.” By Sally Satel. [The moral panic over teens and e-cigarettes is clouding judgment.] 5-16-18
- FDA. “More Competition for Pharma.” [The FDA calls out companies that duck the law on generics.] 5-19-18
- FDA. “A Risky Drug Approval Lesson” [What the FDA can learn from progress against muscular dystrophy.] 7-5-18
- 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
- FDA. “A Shot of Competition for EpiPen.” [the FDA removes a barrier to approval of ‘complex generis.’] 8-20-18
- 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
- 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
- FDA. “More Lawsuits = Higher Drug Prices.” [The FDA pulls an Obama rule that was a trial-lawyer special.] 12-19-18
- FDA. “Fighting a Tort Plague.” [Should a drug company be punished for following FDA rules?] 1-7-19
- 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
- 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
- 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
- FDA. ”Thank You for Not Vaping.” 1-3-20
- 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
- FDA. “The FDA’s Good Plasma Decision.” [Ignore Trump’s tweet. This is the right decision based on the science.] 8-25-20
- 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
- FDA. “The FDA’s Political Inoculation.” [Thy the U.K. has approved a vaccine faster than the U.S.] 12-4-20
- FDA. “Liberation Day for French Dressing.” [The FDA also eases its vigilance over cherry pie standards.] 12-28-20
- FDA. “The Battle Over an Alzheimer’s Treatment.” [Biogen’s promising drug is caught in the FDA’s bureaucratic limbo.] 4-20-21
- 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
- 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
- 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
- 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
- FDA. “The FDA Misses Its Hit on Juul.” [After it was sued, the agency admits that it ignored key evidence.] 7-8-22
- FDA. “A Biden Hearing-Aid Breakthrough.” [A new FDA rule will allow more competition and reduce prices.] 8-17-22
- FDA. “The FDA and an ALS Treatment.” [A new drug offers rare hope for patients if the agency approves it.] 9-13-22
- FDA. “The Zantac Scare and Junk Science.” [A federal judge exposes the false claims behind a trial-lawyer assault.] 12-9-22
- FDA. “The U.S. Department of Masara.” [The omnibus bill gives the FDA new power to police the beauty aisle.] 12-21-23
- FDA. “The FDA Returns to Its Bad Habits.” [The agency may nix a new treatment for an orphan disease.] 2-21-23
- 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
- FDA. “FDA Commissioner Gets Political.” [Robert Califf’s job is safety and efficacy, not drug prices.] 6-12-23
- FDA. “Court to FDA: Stop Playing Doctor.” By Joel Zinberg. [The Fifth Circuit revives a lawsuit over advice against taking ivermectin for Covid.] ] 9-15-23
- 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
- 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
- FDA. “The FDA’s Laboratory Land Grab.” [The agency wants to treat academic lab tests like medical devices.] 10-11-23
- FDA. “Requiem for an Alzheimer’s Drug.” 2-1-24
- 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 other options.] 2-28-24
- FDA. “Requiem for a Drug Maker.” [After 24 years In business, an innovator hit the FDA’s roadblock.] 4-8-24
- FDA. “An Alzheimer’s Advance, Not a Cure-All.” By Howard Fillit. [Donanemab promises progress. The FDA shouldn’t hold out for perfection.] 6-10-24