To Bring Down Big Pharma, This BioHacker Wants To Teach Patients To Make Own Medications

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Michael Laufer’s latest plan involves developing a desktop lab and a recipe book meant to equip patients to cook up a range of medicines, including a homemade version of the expensive hepatitis C drug Sovaldi, on their kitchen counters. In other news: an old FDA program is responsible for higher drug prices and lawmakers want more oversight over the 340B program, which allows hospitals to purchase drugs at a discounted rate.

Stat: An Anarchist Takes On Big Pharma — By Promoting DIY Prescription Drugs
Swaggering, charismatic, and complex, Michael Laufer has become a fixture in the growing biohacker movement ever since he published plans last year for a do-it-yourself EpiPencil — a $35 alternative to the pricey EpiPen. It’s not clear whether anyone has actually ever used a homemade EpiPencil to prevent anaphylactic shock. But that seems almost an afterthought to Laufer’s bigger goal — trying to build a DIY movement to attack high pharma pricing and empower patients. (Piller, 10/12)

Stat: An FDA Program To Approve Old Drugs Causes Higher Prices And Shortages
In 2006, the Food and Drug Administration launched a program to require drug makers to win approval of medicines that — believe it or not — were being sold without the agency’s imprimatur or remove them from the market. At the time, hundreds of treatments were readily available because some companies failed to comply with a 1962 law mandating companies prove drugs were effective. …More medicines may have received needed regulatory approval, but often enough, shortages ensued, prices rose, and there was no new clinical evidence to support the vast majority of the medicines that were approved, according to a new study published in the Journal of Managed Care & Specialty Pharmacy. (Silverman, 10/11)

Stat: D.C. Pharmacist Has Something To Say About That Alzheimer’s Remark
The pharmacist who prepares prescription drugs for Congress would like you to know that he does not know of any members with Alzheimer’s. And if he did, he wouldn’t tell you. “I am not aware of any member that actually has Alzheimer’s and would certainly not disclose any such information if I did know,” Mike Kim said, adding that “patient privacy is a very serious matter that I am committed to upholding.” (Mershon, 10/11)

Modern Healthcare: Lawmakers Worry Providers Are Abusing The 340B Program
Federal lawmakers said Wednesday that the 340B program that allows hospitals to purchase drugs at discounted rates does not have enough oversight, leaving it susceptible to misuse. Approximately 45% of all acute-care hospitals participate in the 340B program, which has grown significantly. The Medicare Payment Advisory Commission estimates that 2,140 hospitals participated in the program in 2014, up from 583 in 2005. Program spending during that period jumped from $2.4 billion to $14 billion, according to federal data. (Dickson, 11/11)

Morning Consult: House Republicans Ramp Up Scrutiny Of Providers In Drug Discount Program
House Republicans are intensifying scrutiny of a federal program that gives thousands of safety-net providers hefty discounts on prescription drugs but that they say doesn’t have effective tools to track where the savings are going. The 340B Drug Pricing Program makes some providers, such as children’s hospitals, federal health centers and specialty clinics, eligible for discounts of between 25 to 50 percent on outpatient drugs. Providers are supposed to use the generated savings to ensure low-income patients have access to essential health services and treatments. … At a hearing on Wednesday, the [Energy and Commerce] committee’s chairman, Greg Walden, (R-Ore.) said some providers recently interviewed by the committee don’t have policies in place to ensure all their eligible patients directly benefit from the program or track their 340B savings on a regular basis. (Reid, 10/11)

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