Drug Development: Too Fast, Too Soon

By: Jessica Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com

Everything in our world today runs at a fast pace, and the pharmaceutical industry is certainly no exception. In order to stay competitive in the market, pharmaceutical companies are pushing hard to develop and promote new drugs faster than ever before. The problem is that this fast-paced development shifts the focus from patient safety to creating revenue.

Several horror stories of drugs being placed on the market too soon, only to be quickly withdrawn, are well familiar: Vioxx, the anti-inflammatory drug associated with causing heart attacks and strokes, was withdrawn in 1999; Baycol, the cholesterol-lowering drug associated with adverse muscular reactions, was withdrawn in 2001. But those aren’t the only examples. Almost a decade later, the trend of sending insufficiently studied, and sometimes dangerous, drugs into the market continues.

Withdrawing a product from the market, whether voluntarily or not, can hurt a company’s reputation in many ways, but the bottom line is that a withdrawal causes consumers to lose faith in the company and all of the products that it manufactures. This translates into, at best, a loss of revenue and at worst, costly litigation. So how can companies develop new drugs, but avoid the possibility that they could be withdrawn from the market?

One of the main criteria the FDA looks for when approving a new drug is whether it is safe, and whether the benefits outweigh the risks[1]. The finger of blame could possibly be pointed at the FDA for approving drugs too quickly, but it is also the responsibility of pharmaceutical manufacturers to provide the FDA with all information available to make its decision. If drugs are not being sufficiently examined within the appropriate test groups, then it is impossible to give the FDA the information it needs to make a responsible decision. Many studies have shown that the FDA is underfunded, and because of the Prescription Drug User Fee Act (PDUFA), it must review 90 percent of all drug applications within 10 months of submission, or face further funding reductions[2]. This puts pressure on the FDA to make potentially hasty decisions, so it is up to manufacturers to present the most thorough information possible, to assist the FDA in making the best approval decisions possible.

How should the “most thorough information” be obtained? Common sense would tell us that the best way to avoid product withdrawals is to design clinical trials that focus on short AND long-term side effects in patients. A study published in the Annals of Oncology researched 25 clinical trials over a ten year period, and found that each lasted around 30 months once benefits were found in patients[3]. As stated above, the FDA needs to look at the benefits compared to the risks. If clinical trials are cut short just because there are promising benefits, it would be difficult to assess potential long-term risks, which could lead to the FDA approving a drug too soon.

Despite the push to developing drugs faster than ever, the human body is not something that can be rushed. In order to avoid the negative impact that a product withdrawal creates, manufacturers should focus more on long-term testing of associated risks, and less on developing drugs too quickly in eagerness for revenue. Sometimes the best way to stay competitive is to slow down instead of speeding up.

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1. http://www.fda.gov/cder/regulatory/applications/NDA.htm
2. http://www.hon.ch/News/HSN/613891.html
3. http://www.dailymail.co.uk/health/article-558251/Drug-trials-soon-warn-doctors.html