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Why Does it Take So Long to Get New Drugs Approved?
Feb 13, 2005

In the eighties and nineties activists had to fight for new drugs. Then HAART came along and things got better for people who can tolerate the HAART medications, but those who can't or who run out of options are forgotten.

Why does it take ten years to get new drugs?

It would be okay if this meant ten years of safety testing. However, most drugs are released with less than a year of safety and efficacy data.

A handful of drug companies have a monopoly and don't want competition, even though patients need options. So approvals are timed to maximize profits on drugs already approved.

If the pipeline was handled scientifically instead of politically wouldn't it be possible to make new drugs available in two or three years at most, with the same level of data that is now slowly drawn out in Phase I, II, and III and delays in between?

Response from Dr. Pierone

I think that you bring up some valid points, but there are some additional considerations.

Those who have run out of options are not forgotten. There are numerous agents actively being pushed through the pipeline to meet this need. A partial list includes Tipranavir, TMC-114, TMC-125, Reverset, Pfizer CCR-5 inhibitor, Glaxo CCR-5 inhibitor, TNX-355.

From the time a chemical with antiretroviral activity in the test tube is identified, there are multiple steps that must be completed. There are safety studies in cell models, small animals, and then larger animals before a drug company can even think of giving it to a human. Then phase 1 human trials involving safety, phase II trials for more safety and efficacy, then large phase III trials for more safety and efficacy. These must be done sequentially and take years to complete. So it would not be possible to make new drugs available in 2 or 3 years without sacrificing crucial safeguards.

Have pharmaceutical companies abandoned drugs or delayed them because they compete with approved agents or there is not commercial potential? Yes, this does happen. For example, Roche dropped plans for T1249 when it became clear that T20 was not going to be the commercial success that they had hoped for.

Can the government step in and do a better job? Based on my experience dealing with government sponsored research consortiums, I think not. Slow, cumbersome, and bureaucratically challenged are the watchwords here. The NIH has probably spent about a gazillion dollars studying IL-2 over the past 10 years. This work is well intentioned, but very expensive, and IL-2 is clearly not a breakthrough agent for HIV.



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