An analysis by the Institute of Medicine found that the federal system for approving and regulating drugs has serious problems, and dramatic changes are required to fix them.
The report fixed the blame on the FDA, Congress, and the pharmaceutical industry, and called on all of them to share responsibility in implementing solutions.
Several of the suggested changes are ones that have been requested for many years by drug safety advocates.
Many of the recommendations would require Congressional approval to enact, including such changes as:
- FDA commissioners would serve a single six-year term
- Newly approved drugs would include black triangles on their labels, warning consumers their safety was still in question
- New drugs would only be approved for five years, at which point the FDA would review their safety
- A ban on advertising would be in effect while drugs remain on this probationary period
The panel also recommended that a substantial majority of FDA advisory panel members not have industry ties, and suggested that manufacturers should be required to produce the outcomes of all studies, not just those published in medical journals. Studies that show positive results for a drug are more likely to be published.
With the current Congressional session nearly over, there's no hope that any of these reforms will be considered before next year, when federal legislators will reconsider the existing agreement with the multi-national drug companies, under which they pay millions to speed up reviews of new drugs.
Under current law, those fees cannot be diverted to shore up the agency's woefully underfunded safety division.
Of course, the drug cartel's minister of propaganda, Pharmaceutical Research and Manufacturers of America, would have you believe any notion the FDA is seriously compromised is a big mistake.
They oppose the mandatory registration of clinical trials, arguing that this would force companies to reveal trade secrets, and they also oppose any restrictions on advertising. It's fairly easy to see where they stand on the issue of making money versus ensuring patient safety.
However, the real mistake would be trusting the FDA's opinions about drug safety, especially considering it can't even assess its own success or failure, according to Sen. Charles Grassley (R-Iowa).
We'll have to wait and see if these recommendations cause any actual changes. The drug companies significantly influence American political leaders that are responsible for FDA policies and funding. From 1998 to 2005, drug and chemical corporations spent $758 million on lobbying politicians.
In the 2004 elections alone, nearly $1 million was contributed to President Bush, $500,000 to his opponent John Kerry, and over $100,000 was contributed to approximately 18 members of Congress.
The drug and chemical industries employ over 1,200 full-time lobbyists, including 40 former members of Congress. The drug and chemical corporate lobbyists are extremely successful at what they do, which puts the FDA at the mercy of the very same chemical industry that they aim to regulate.
So, the odds are stacked against any real changes.
Don't count on the FDA. People need to take responsibility for their own health and: