...the Obama administration wants to add another obstacle to new drug development.
The health section of the new stimulus budget contains a section funding - at a $1.1 billion level - a program to evaluate drugs (and procedures) for "comparative effectiveness" (CE).
If followed to its logical conclusion, the FDA will no longer approve a drug if CE studies show that it's merely safe and effective. Henceforth, it would have to be proven better than similar drugs already on the market. If adopted, this will lead to major declines in the already-stunted drug pipeline and fewer choices for consumers.
The handwriting on the wall was exemplified recently when Pfizer, the world's largest pharmaceutical company, halted development of two new drugs during late-stage trials, after many millions of research dollars had been spent. This unusual timing - failed drugs get scrapped in their early stage trials, as a rule - occurred because, according to Pfizer, "We don't believe that they provide significant benefit over other therapies." Imagine if we held other consumer products and manufacturers to this standard: No new TVs, computers or autos would be marketed without clear evidence the newer models were "better" according to some arbitrary government standard.
Please read Dr. Ross’s full commentary.
Let me give you an example of how this could play out in the future. Cimetidine was the first of a class of drugs to fight excess stomach acid in cases of peptic ulcers and gastroesophageal reflux disease. Several other “me too” drugs followed. Eventually, it was found that cimetidine has significant drug interactions that its successors did not possess. It would even interact with grapefruit juice in a way that could cause serious side effects. It was taken off the market, but there were plenty of alternatives for patients to use. Under the FCCCER system, none of those successive drugs would have been available because they did not show a significant clinical advantage over the original drug, cimetidine. Patients would have to wait for an alternative to go through the development process (often 10-15 years) and then the approval process.
What happens if something similar occurs with a new vaccine, for example a vaccine against tuberculosis? No one will develop a competitor once an effective vaccine is approved. Then perhaps the original vaccine shows evidence of a serious side effect and has to be pulled. There is nothing to replace it. A highly contagious and difficult to treat disease becomes a threat when it could have been prevented if an alternative vaccine had been developed.
The United States is the center of new medical developments precisely because we have a free market system. The system proposed by President Obama will bring that to an end.