PracticeLink Magazine

Summer 2019

The career development quarterly for physicians of all specialties, PracticeLink Magazine provides readers with feature articles, compensation stats, helpful job search tips—as well as recruitment ads from organizations across the U.S.

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34 S UMMER 2019 PracticeLink.com ▼ T HE In T E rv IE W ISSUE D E P A R T M E N T S Reform Recap J e FF A t KI n SO n More drugs on the fast track The FDA uses multiple processes to bring high - value drugs to market more quickly. I n t H e LAS t 20 Y e A r S, t H e n UMB er OF D r UGS t HA t HA ve B een G r A nte D FAS t tr ACK S t A t US BY t H e F e D er AL FOOD A n D D r UG ADMI n IS tr A t IO n HAS I n C re AS e D BY MO re t HA n FI ve -FOLD. The program, which began in 1998, granted Fast Track designation to 21 drugs in its first year and 108 drugs in Fiscal Year 2017. The program was authorized by Congress in 1997 through the Food and Drug Administration Modernization Act. In the words of the statute, the program is designed to expedite development and review of drugs "for the treatment of a serious or life-threatening disease or condition" when the drug company demonstrates the drug's "potential to address unmet medical needs for such a disease or condition." The goal is to get important new drugs and biologics to patients more quickly. Origin during AIDS crisis The impetus for the Modernization Act was the AIDS/ h IV crisis, during the early stages of which there were no effective treatments. The first accepted Fast Track product was the AIDS drug Efavirenz. Determination of whether a drug is eligible for the program involves consideration of multiple factors, including the drug's likely impact on survival, day- to-day functioning, and the degree to which the condition, if left untreated, will progress to a more serious condition. The FDA provides examples of such conditions: A IDS, cancer, heart failure, Alzheimer's and severe bacterial and fungal infections. Diabetes, depression, and epilepsy also can be considered serious. Methods of expediting approval Drug companies can apply for Fast Track designation at any time during the process of drug development, including at the time of submission of the Investigational New Drug (IND) application. Under the Modernization Act, the FDA is directed to act on a drug company's request for the designation within 60 calendar days of receipt of the request. In recent years, between 70 and 80 percent of Fast Track applications have been granted. Once an application has been granted, the drug becomes eligible for different types of special treatment from the FDA. The FDA will meet more frequently with drug companies regarding Fast Track products than products that are not Fast Track designated. In addition, drug companies can submit completed sections of a New Drug Application (NDA) or Biological License Application (B l A) and obtain prompt review rather than waiting for the entire application to be complete. This process is referred to as a "rolling review."

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