Consumer Advocates Raise Concerns About FDA’s Efforts To Speed Drugs To Market
They charge the Food and Drug Administration is too close to the pharmaceutical industry and the effort to move drugs through the regulatory process faster is contributing to rising prices. Meanwhile, a new analysis finds that the agency's user fees have brought in more than $7 billion since 1992. In other news, there are concerns in Europe, too, about fast-tracking drug approval, a ballot measure in California brings a massive drug industry counterpunch and a cystic fibrosis trial ends.
Politico Pro:
Consumer Groups Take Aim At PDUFA
At a meeting where FDA and industry praised the Prescription Drug User Fee process, consumer advocates charged the agency with being too cozy to industry and contributing to high prices of drugs by focusing excessively on speeding them to market. Part of the user fees that companies pay to have their drugs reviewed more quickly should go to fund an independent review of how PDUFA has affected overall public health, said Paul Brown of the National Center for Health research. (Karlin-Smith, 8/15)
Morning Consult:
FDA User Fee Revenue Exceeds $7B, Analysis Shows
User fees have brought in $7.67 billion since pharmaceutical companies began paying the fees in 1992, according to an analysis released Monday by Avalere Health. The fees are paid by pharmaceutical manufacturers and were created to speed drug approvals by the Food and Drug Administration. The fees have increased every year since 1992, mostly because of higher application fees, according to Avalere, an independent consulting company. ... But the FDA expects to reduce its collections for fiscal year 2017, having “significant leftover collections from the previous 4 years,” the analysis reads. The 2017 data is estimated based on the rate fee established by the FDA. (McIntire, 8/15)
Stat:
European Program For Speeding Some Drug Approvals Criticized
In pointed remarks, Germany’s cost-effectiveness watchdog has criticized an effort by European regulators to accelerate approval for new medicines based on limited evidence. And the concerns raised by the agency come as regulators on both side of the Atlantic increasingly look to such approaches to get new drugs to patients with unmet medical needs. At issue is a proposal called adaptive pathways, a term used to describe a method for jumpstarting drug approvals for select patient populations. (Silverman, 8/15)
The Hill:
California’s 2016 Ballot: ‘Sex. Drugs. Guns. Death.’
Two measures relating to health care have been especially costly: Supporters of Proposition 52, which relates to hospital fees, have raised $59 million so far; opponents have contributed more than $14 million. Backers of Proposition 61, which would limit prescription drug prices, have poured $9.4 million into their campaign. In response, pharmaceutical companies have spent nearly $70 million to quash the measure. (Wilson, 8/15)
The Boston Globe:
Vertex Ends Trial Of Cystic Fibrosis Drug Combination
Vertex Pharmaceuticals Inc. said Monday it is ending a clinical study testing a two-drug combination therapy on a small group of cystic fibrosis patients after an independent board concluded the experimental treatment wasn’t showing meaningful benefit. The announcement sent shares of the Boston-based biotech company down more than 2 percent in after-hours trading. (Weisman, 8/15)
