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HOME > Review > A kinder, gentler FDA or the exception to the rule?
A kinder, gentler FDA or the exception to the rule?

Approval of Velcade for multiple myeloma

On May 13th the FDA approved the novel cancer drug Velcade, made by Millennium Pharmaceuticals Inc. (MLNM), as a treatment for multiple myeloma. Velcade is the first of a new class of medicines called proteasome inhibitors which blocks the proteolytic activity of the proteasome. By blocking the proteasome, Velcade disrupts numerous biologic pathways, including the failure to degrade IkB, which thus remains bound to NF-kB instead of being degraded. By disruption of the signaling action of NF-kB a multitude of genes needed for the proliferation and adhesion of cancer cells are downregulated. Furthermore, it is believed that in solid tumors this mechanism would inhibit angiogenesis (new blood vessel formation). Velcade is currently in trials in several solid tumor types.

Time from first in human to approval

The time to approval was extremely rapid. The approval was 4.5 years from first in human to market release. In fact, as I understand it, the approval was granted by looking at response rates and not survival time. It makes one wonder in the post approval monitoring if there turns out to be minimal survival benefit if it will be recalled. It has been stated that MLNM worked hand in hand with the FDA and even the expedited approval process took two months less than expected. It is unclear what effect this quick approval will have on current drug development, as some are advocating the expansion of the FDA's subpart H program, which allows for the accelerated approval of drugs that address life-threatening diseases.

Velcade vs. normal FDA course

The normal course of FDA approval is that it takes 7-10 years from IND filing to approval of a new drug and at a cost of $500 million to $800 million. This researcher has personal knowledge of phase III trials which the FDA required extensive monitoring that pushed the price tag close to $500 million for the phase III alone. This major price tag shuts out all but the most well funded companies from carrying their own products to approval. A main reason drugs are so expensive in this country is the increasing regulations that come with approval. Before prescription drugs can become cheaper, there must be reforms at the FDA. Let's hope that the expedited approval of Velcade in the beginning of that reform process.

Why is this the exception?

Many websites such as Consumers Against High Drug Prices (http://www.stopfda.org/) put forth that the clinical trial process and the FDA is to blame for the high cost of drugs in the United States vs. other countries. They make a lot of valid points about how small companies cannot develop drugs effectively because the massive amounts of money it takes to successfully navigate the approval process. They go further than that the FDA and major drug companies work together to construct the system to prevent small innovative companies from growing and challenging their market share (I don't share thier view).

The solution proposed by much with those who believe as they do is that the FDA regulations should be relaxed or eliminated and allow a "free market" to emerge where companies that make good drugs will survive and companies that make bad drugs will go out of business. In that type of world there would be no investment in biotech or pharma by venture capital due to an unacceptable risk profile and drug development would suffer dramatically. There are no statistics on adverse drug reactions before the implementation of the current clinical trial process, but one can assume that there were considerably more cases of ADRs.

We don't need to scrap the clinical trial process as some would advocate, but it certainly needs a significant overhaul. When doing this overhaul it should be considered that less extensive clinical testing would certainly shift the burden to the patient and physician to better understand of the risks and benefits of medication and would require more extensive post-approval monitoring of drug performance. A start would be to take a hard look at the success in implementation of the subpart H program...


Remember this quote? "We believe that ephedra-based products are safe when used as directed," GNC President and Chief Executive Michael Meyers said. "Nonetheless, the current business climate dictates that we move in a different direction."

Illinois bans ephedra: On Sunday, May 25, Governor Rod Blagojevich signed into law Senate Bill 1418, making Illinois the first state in the U.S. to ban the sale of ephedra. The legislation makes it a misdemeanor to sell or offer for sale "any quantity of ephedra or ephedrine alkaloids" to anyone in the state of Illinois, and is punishable by up to five years in jail and a $20,000 fine.

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