freshjiva
02-25-2011, 12:52 PM
This is it. ANY discussions for how to bring healthcare costs under control MUST INCLUDE COMPLETE FDA REFORM, starting with stripping their powers of being a complete monopoly over the approval/rejection of new drugs.
Today, the FDA issued a "Complete Response Letter", which is issued when the FDA declines to approve a drug, to Protalix Biotherapeutics. This was a company that has been developing a new therapy for patients suffering from Goucher's diease using a proprietary recombinant protein system. It was supposed to offer a significant cost effective alternative to existing therapies.
In the conference call this morning, the CEO said that they did everything the FDA asked for: FDA-approved trial design, FDA approved safety/efficacy data, and all supplemental manufacturing inspections. They did everything they were supposed to in order to gain approval, and spent a cumulative $500 million over 6 years of research and development.
The FDA said they need to see additional data before making a decision. They could have simply asked for this to begin with instead of slamming the company, delaying approval, and costing the company millions more.
This is just a tiny blimp on the radar. There have been scores of cases like this where the FDA has been nontransparent, unclear on what they're looking for, inefficient at keeping up with new drug applications, and most importantly, made decisions based on arbitrary opinions. If we want drug prices to decline, the FDA needs to be at the forefront of ANY healthcare discussion.
I've been following the drug & biotechnology sector for several years now, and here's my "moderate" pitch on what public policy can be implemented IMMEDIATELY:
1) Strip the FDA's monopoly over deciding the fate of drugs by opening up the discussion to the private sector; allow doctors/nurses/patients that would directly be impacted by any new drug to discuss and VOTE on approval and labeling
2) Require the FDA to approve any drug that has been developed under the SPA (special protocol assignment). This gives drug companies definitive CLARITY on what they need to show in order to get approval.
These are two things we can do immediately. Ultimately, the FDA should be completely phased out and allow the free market of doctors/nurses/scientists/patients to determine the safety and efficacy profile of all new drugs. We don't need a small panel of bureaucrats at the FDA to claim to be more intelligent than the medical community at large.
Sorry, I'm just venting because I've seen this happen just too many times. Drug companies are the target of a LOT of scrutiny, more than they would be under a true free market in medicine. No wonder why healthcare is a complete disaster in this country. We're proposing all the wrong solutions and not attacking the roots of the problem, one of which is the power-hungry FDA itself.
Today, the FDA issued a "Complete Response Letter", which is issued when the FDA declines to approve a drug, to Protalix Biotherapeutics. This was a company that has been developing a new therapy for patients suffering from Goucher's diease using a proprietary recombinant protein system. It was supposed to offer a significant cost effective alternative to existing therapies.
In the conference call this morning, the CEO said that they did everything the FDA asked for: FDA-approved trial design, FDA approved safety/efficacy data, and all supplemental manufacturing inspections. They did everything they were supposed to in order to gain approval, and spent a cumulative $500 million over 6 years of research and development.
The FDA said they need to see additional data before making a decision. They could have simply asked for this to begin with instead of slamming the company, delaying approval, and costing the company millions more.
This is just a tiny blimp on the radar. There have been scores of cases like this where the FDA has been nontransparent, unclear on what they're looking for, inefficient at keeping up with new drug applications, and most importantly, made decisions based on arbitrary opinions. If we want drug prices to decline, the FDA needs to be at the forefront of ANY healthcare discussion.
I've been following the drug & biotechnology sector for several years now, and here's my "moderate" pitch on what public policy can be implemented IMMEDIATELY:
1) Strip the FDA's monopoly over deciding the fate of drugs by opening up the discussion to the private sector; allow doctors/nurses/patients that would directly be impacted by any new drug to discuss and VOTE on approval and labeling
2) Require the FDA to approve any drug that has been developed under the SPA (special protocol assignment). This gives drug companies definitive CLARITY on what they need to show in order to get approval.
These are two things we can do immediately. Ultimately, the FDA should be completely phased out and allow the free market of doctors/nurses/scientists/patients to determine the safety and efficacy profile of all new drugs. We don't need a small panel of bureaucrats at the FDA to claim to be more intelligent than the medical community at large.
Sorry, I'm just venting because I've seen this happen just too many times. Drug companies are the target of a LOT of scrutiny, more than they would be under a true free market in medicine. No wonder why healthcare is a complete disaster in this country. We're proposing all the wrong solutions and not attacking the roots of the problem, one of which is the power-hungry FDA itself.