It is time to abolish the FDA.

[freshjiva]

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.

[iamse7en]

The FDA is not only unconstitutional, but it gives unelected bureaucrats the power to choose which substances (food and drugs) are allowed in the marketplace, when and where people can buy them, and influence who can buy them. What a gross obstruction of liberty, not to mention the "unintended consequences" (I put in quotes, because to some they are INTENDED) in which thousands of deaths are caused by preventing a certain drug from being purchased in the marketplace.

Thanks for your post.

[tangent4ronpaul]

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

won't work. Big pharma companies that had a more expensive drug for the same thing would simply go on an advertising blitz to influence that voting in their favor.

Before the FDA got involved with this, drug companies did enough testing to be comfortable that they wouldn't get sued. It took 2 years on average instead of up to 12 years, cost was tens of thousands, mot millions, drugs were cheap and more drugs were developed, especially the ones with small or poor markets that are not developed today because it would be unprofitable to do so due to FDA regulations.

-t

[freshjiva]

won't work. Big pharma companies that had a more expensive drug for the same thing would simply go on an advertising blitz to influence that voting in their favor.

Advertising only works for the masses. I'm talking about the free market analyzing the clinical trial data themselves and arriving at their own conclusion. The free market of doctors, nurses, scientists, and patients who are intimately familiar with the particular medical condition do not vote based on advertised benefits, for the most part.


Before the FDA got involved with this, drug companies did enough testing to be comfortable that they wouldn't get sued. It took 2 years on average instead of up to 12 years, cost was tens of thousands, mot millions, drugs were cheap and more drugs were developed, especially the ones with small or poor markets that are not developed today because it would be unprofitable to do so due to FDA regulations.

Agreed.

Just today, the FDA issued a "refusal to file" letter to a company called Santurus for their new drug to treat angioedema, a genetic disorder. The FDA basically said they think the company's Phase III clinical trials did not include enough patients to arrive at statistically significant conclusions. Why did the FDA wait until AFTER the trials were conducted to bring up this simple issue? They couldve let the company know far in advance.

This is just another example in the LONG LIST of reasons why the FDA is directly destroying the drug/biotech sector in this country, and why healthcare costs will never be remedied unless we either reform or completely abolish the FDA.

[roho76]

The FDA is a product of the major players of Big Rx/Insurance. As long as they're in business so will be the FDA. These are the new monopolies.