Perspectives: Welcome To The Real World Of Prescription Drug Regulation

Stat: The FDA And Sarepta: A Window Into The World Of Drug Regulation
It is hard to discern the true state of drug regulation from the outside, but two recent decisions by the Food and Drug Administration — to approve one drug but reject another — offer a rare glimpse into that world. Exondys 51 and Vyondys 53, both developed by Sarepta Therapeutics (SRPT), are intended to treat a severe form of muscular dystrophy, though in different subgroups of patients. Exondys 51 gained FDA approval in 2016 amid great controversy. Agency officials were divided because evidence of the treatment’s benefits was especially thin. Its approval came with a condition requiring Sarepta to carry out a post-approval clinical trial to confirm the drug’s effectiveness. (Matthew Herder, 9/3)

The Hill: Bad Medicine: The Value Of Monitoring Banned Drugs
While there are no easy answers, the Drug Enforcement Agency (DEA) database and our recent research forthcoming at Social Science and Medicine indicates that there is value in tracking and monitoring banned medicines with detailed nationally representative databases. Perhaps targeted monitoring using anti-counterfeiting technologies will also help, and so will naming and shaming firms using insights from behavioral economics. Another answer might be in setting up a global body that harmonizes enforcement standards across rich and poor countries, as research from Amir Attaran and his coauthors has indicated. (Chirantan Chatterjee, 8/28)

San Francisco Chronicle: AB824 Is Supposed To Make Medications More Affordable To Californians. It Won’t.
AB824 is legislation that would bar companies from settling patent disputes for generic medicines by using economic “pay-for-delay” agreements with the proprietary drug’s manufacturer. These agreements are between drug makers and generic companies, and they extend the amount of time the drug maker has to provide the sole offering of a drug on the marketplace. (Wendye Robbins, 8/29)

Stat: Enough With The Me-Too Drugs. New Treatments Should Be Worthy Of The People Who Invest Their Lives In Clinical Trials
Like many people starting out in the biotech industry, I wanted to make an impact on people’s lives by developing life-changing therapies. But I’ve become disappointed by what I believe are too many companies pushing mediocre and me-too drugs, also known as copycat drugs, into clinical development where they will likely fail. Clinical trials are more than a way to test new therapies. They offer very sick people hope and a chance for more time with their loved ones. Lately, the drug development process has turned into an exercise in me-tooism — at patients’ expense. It’s time to shift the focus back to those who matter most. (Gail McIntyre, 9/4)

Bloomberg: This Drugstore Is A $3 Billion Headache
Take Hong Kong protests, add a dash of Brexit and then stir in the death of brick-and-mortar shopping. It’s hardly surprising that a savvy investor would want to bail from its stake in A.S. Watson Group, a retailer based in the former British colony with a big U.K. footprint. These latest geopolitical flash points have been cited for Temasek Holdings Pte’s decision to table the sale of its $3 billion interest in A.S. Watson, Bloomberg reporters Manuel Baigorri, Joyce Koh and Vinicy Chan wrote Wednesday. (Nisha Gopalan, 9/4)

FierceHealthcare: $3K For Folic Acid? CVS Caremark Takes Aim At 'Hyperinflated' Drug Prices
CVS Caremark is saving money on drug costs by kicking specific products with high inflation off their formularies. The pharmacy benefit manager (PBM) launched its program for “hyperinflation” drug removals in 2017 in which it will take drugs off its template formulary if they have far cheaper equivalents and their high prices aren’t backed by quality metrics. So far, they've identified five drugs to remove as the default option for docs. (Paige Minemyer, 8/29)

Norfolk Daily News: New Data Shows Impact Of Rising Drug Prices On Nebraskans
According to new state data released by AARP Nebraska, 31% of Nebraskan adults have stopped taking a prescription drug because of rising costs. Americans currently pay at least twice what people in other developed countries pay for the same medicine, and AARP Nebraska is urging its members to lean on the state's congressional delegation. Bob Lassen, AARP Nebraska executive council volunteer, says as drug prices continue to rise, Americans are being forced to make difficult decisions. (Eric Galatas, 9/3)

Delaware State News: Delawareans Need Relief From Rx Greed
For decades, big drug companies have raised drug prices while thousands of people in Delaware are struggling to make ends meet. Between 2012 and 2017, the average annual cost of brand name prescription drug treatment in our state has increased 58%, while the annual income for Delawareans increased only about 9 percent. Prescription drugs don’t work if patients can’t afford them. That’s why Congress needs to pass the Prescription Drug Pricing Reduction Act. It’s time. (Lucretia Young, 9/2)