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Fast Track Drugs Come to Market in the U.S. with FDA Cooperation, Business and Industry Trends Analysis

Despite exponential advances in biopharmaceutical knowledge and technology, biotech companies enduring the task of getting new drugs to market continue to face long timeframes, daunting costs and immense risks.  By one count, of every 1,000 experimental drug compounds in some form of pre-clinical testing, only one makes it to clinical trials.  Then, only one in five of those drugs make it to market.  Of the drugs that get to market, only one in three bring in enough revenue to recover their costs.  Meanwhile, the patent expiration clock is ticking—soon enough, manufacturers of generic alternatives steal market share from the firms that invested all that time and money in the development of the original drug.

Internet Research Tip:
The FDA regulates biologic products for use in humans.  It is a source of a broad variety of data on drugs, including vaccines, blood products, counterfeit drugs, exports, drug shortages, recalls and drug safety.

     The FDA is attempting to help the drug industry bring the most vital drugs to market in shorter time with programs that include:  Fast Track, Priority Review, Breakthrough Therapy Designation and Accelerated Approval.  The benefits of Fast Track include scheduled meetings to seek FDA input into development as well as the option of submitting a New Drug Application in sections rather than submitting all components at once.  The Fast Track designation is intended for drugs that address an unmet medical need, but is independent of Priority Review, Breakthrough Therapy Designation and Accelerated Approval.  Priority drugs are those considered by the FDA to offer improvements over existing drugs or to offer high therapeutic value.  The priority program, along with increased budget and staffing at the FDA, is having a positive effect on total approval times for new drugs.  Breakthrough therapies show early clinical evidence of very important improvements over currently available drugs.
The FDA quickly approved Novartis’ drug Gleevec (a revolutionary and highly effective treatment for patients suffering from chronic myeloid leukemia).  After priority review and Fast Track status, it required only two and one-half months in the approval process.  This rapid approval, which enabled the drug to promptly begin saving lives, was possible because of two factors aside from the FDA’s cooperation.  First, Novartis mounted a targeted approach to this niche disease.  Its research determined that a specific genetic malfunction causes the disease, and its drug specifically blocks the protein that causes the genetic malfunction.  Next, thanks to its use of advanced genetic research techniques, Novartis was so convinced of the effectiveness of this drug that it invested heavily and quickly in its development.
Key Food & Drug Administration (FDA) terms relating to human clinical trials:
Phase I—Small-scale human trials to determine safety.  Typically include 20 to 60 patients and are six months to one year in length.
Phase II—Preliminary trials on a drug’s safety/efficacy.  Typically include 100 to 500 patients and are one and a half to two years in length.
Phase III—Large-scale controlled trials for efficacy/safety; also the last stage before a request for approval for commercial distribution is made to the FDA.  Typically include 1,000 to 7,500 patients and are three to five years in length.
Phase IV—Follow-up trials after a drug is released to the public.
Generally, Fast Track approval is reserved for diseases that are life-threatening and have no current therapies, such as rare forms of cancer.  However, new policies are setting the stage for accelerated approval of drugs for less deadly but more pervasive conditions such as diabetes and obesity.  Approval is also being made easier through the use of genetic testing to determine a drug’s efficacy, as well as the practice of drug companies working closely with federal organizations.  

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