House Expected To Hold Hearings On ‘Right-To-Try’ Bill That Senator Tied To FDA Funding
The Senate quickly passed the bill that would allow dying patients access to experimental drugs after Sen. Ron Johnson (R-Wis.) had threatened to slow down consideration of a separate bill to renew the FDA’s fee-collection authority. In other drug industry news, the FDA is implementing new rules about hiring foreign scientists, industry tightens controls to keep out counterfeit drugs, cancer trials are low on patients and costs of old drugs rising quickly for Medicaid.
Roll Call:
‘Right To Try’ Bill Could Face Slower Action In House
A Senate-passed bill intended to help dying patients access experimental drugs will likely face lengthier deliberations in the House. While the Senate fast-tracked the bill on Aug. 3, the House will likely subject it to a hearing and markup before bringing it up to a vote, according to congressional aides and a lobbyist. (Siddons, 8/14)
Stat:
FDA Puts New Restrictions On Hiring Of Foreign Scientists, Documents Show
The Food and Drug Administration is implementing a new hiring protocol that could make it significantly harder for foreign scientists to find jobs and research opportunities at the agency, according to interviews and newly obtained documents. The FDA recently began directing hiring managers not to extend any employment offers — including for fellowship and contractor positions — to any individual who has not lived in the U.S. for at least three of the five previous years, according to briefing materials shared with STAT that have been presented to some agency employees. (Mershon, 8/11)
Stat:
With Deadlines Looming, Pharma Companies Look To Tighten Drug Security
Most people trust that their medicine matches the description on the bottle. But what if it doesn’t? Counterfeit drugs look a lot like the real deal, but can contain too little or none of the active ingredients that make a drug work. Or worse, a counterfeit drug can have toxic compounds. (Wosen, 8/14)
The New York Times:
A Cancer Conundrum: Too Many Drug Trials, Too Few Patients
With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical research. There are too many experimental cancer drugs in too many clinical trials, and not enough patients to test them on. The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients. (Kolata, 8/12)
Kaiser Health News:
Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank
Skyrocketing price tags for new drugs to treat rare diseases have stoked outrage nationwide. But hundreds of old, commonly used drugs cost the Medicaid program billions of extra dollars in 2016 vs. 2015, a Kaiser Health News data analysis shows. ... Rising costs for 313 brand-name drugs lifted Medicaid’s spending by as much as $3.2 billion in 2016, the analysis shows. Nine of these brand-name drugs have been on the market since before 1970. In addition, the data reveal that Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year. (Lupkin, 8/14)