The Interceptby David DayenDecember 1, 2016
DRUG MONEY: PART IPOGOby David HilzenrathDecember 1, 2016
DRUG MONEY: PART IIPOGOby David HilzenrathDecember 1, 2016
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End Reliance on User Fees. One way to enhance the FDA’s independence and help prevent the problems identified in this report would be to end the FDA’s reliance on user fees. These are direct payments by manufacturers for certain services provided to them by the FDA. In return, the manufacturers count on special consideration, including faster approvals of drugs. Often “faster” means “less careful” or “less independent.” Congress should not reauthorize the Prescription Drug User Fee Act (PDUFA). Instead, it should use federal appropriations to fund all of the FDA’s work on prescription drugs.
Eliminate Requirement for FDA to Negotiate User Fees with Regulated Industry. A short term solution and a more immediate fix to the problems described in this report would be to eliminate the legislative requirement that the FDA negotiate with “the regulated industry” in advance of user fee reauthorization. Increase Transparency of Negotiation and Consultation Meetings. In the absence of either of the previous suggested changes, Congress should require much more transparency in the user fee reauthorization process. It should open to the public the FDA’s negotiating sessions with industry and its consultation meetings with other stakeholders, including patient and consumer groups. Congress should also require online posting of live webcasts, permanent video recordings, and transcripts of those meetings. Consumer groups that do not receive funding from the pharmaceutical or biotech industries should be included in these meetings. Transparency would allow the public and Congress to better oversee the agreements the FDA negotiates with the drug industry over the agency’s funding and its approach to reviewing drugs. It would help the public and Congress determine whether additional reforms are needed to protect public health and safety. Require Conflict of Interest Disclosure for Stakeholders. POGO’s investigation found that the vast majority of the patient advocacy groups that the FDA consulted in the latest round of user fee meetings received funding from the pharmaceutical industry. Congress should require that all stakeholders who participate in meetings with the FDA over user fee renewal disclose all potential personal and financial conflicts of interest. Those disclosures should be posted online when the meetings take place. The disclosures should include, but not be limited to, industry funding of stakeholder groups, industry representation on the boards and staffs of those groups, and board members who serve as employees or contractors to companies in FDA-regulated businesses—e.g., makers of medical devices and contract research organizations, which manage clinical trials for drug companies.
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I am horribly busy, and I still could not stop reading these exposes of how corrupted the FDA is by drug company money.
Eric
I was the same. I couldn’t stop reading them but couldn’t write about them, at least not yet.
On a related note, http://www.healthnewsreview.org/2016/12/with-media-watchdogs-sidelined-pharma-funded-advocacy-groups-pushed-cures-act-to-the-finish-line/#.WEde_HY-sD8.facebook
We’re in a death spiral of fake oversight and fake regulation. Any attempt to provide additional oversight will in fact be written to give them an advantage over smaller competitors. This isn’t theoretical. It’s exactly what happened with Dodd-Frank. Investment banks not regional banks help cause crisis, now benefit by writing regulations that regional banks can’t cope with. This is why I am not sanguine about grass-roots attempts to reform the FDA.
Frankly I think we’d be better off the model of private regulation of kitchen appliances through a private company, Underwriters Laboratories. Cochran comes to mind as an obvious equivalent. The bond rating agencies used to do a credible job, but now governments go after them if they start downgrading sovereign debt. Then you have the problem of regulators wanting industry jobs as a pay upgrade. See SEC. This is why Martha Stewart went to prison but no one from Goldman Sachs.
In the event that some readers are not cynical enough about the ethical status of “overseers” being less than Clarence the Guardian Angel, get a load of this:
https://www.bloomberg.com/view/articles/2012-09-30/sec-sues-the-one-rating-firm-not-on-wall-street-s-take
Yeah, that’s the ticket. Put the only righteous man in Gomorrah on trial.
For those of you who still have faith in government agencies and the doctors who run them, here’s the surgeon general claiming that e-cigarettes are a tobacco product:
http://www.cnn.com/2016/12/08/health/surgeon-general-report-on-e-cigarettes/index.html?sr=twCNN120816surgeon-general-report-on-e-cigarettes0242PMVODtopLink&linkId=32100333
All of this in the context of CNN’s recent upright zeal about “fake news”.
He’s either an idiot or a political hack who lies for propaganda reasons and he doesn’t seem to be stupid.