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to classify the device and whether any exemptions will apply. It offers a database on its website (fda.gov) where you can search the device name. Or, if you know the panel or medical specialty to which a device belongs, you can go to the panel's web page and identify the device and the corresponding regulations. (The FDA has classifi cations for approximately 1,700 different generic types of devices and has organized them into 16 medical specialties called "panels.") Kamm notes the Division of Industry and Consumer Education (DICE) is a helpful resource for anyone looking to bring a medical device to the marketplace. "They will help you work through what you need to fi nd your way through the regulatory path," he says. The webpage for DICE is at fda.gov, under the Medical Devices heading. Prescription Drug Approvals The goal of the FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in the U.S. are safe and effective. It does not test drugs—the manufacturer of the drug administers clinical trials—al- though its Offi ce of Testing and Research does limited re- search in the areas of drug quality, safety and effectiveness. The center oversees prescription and nonprescrip- tion (over-the-counter) drugs. Companies that apply to launch a new drug in the U.S. are responsible for testing the drug in accordance with the FDA's guidelines and supplying evidence that the drug is safe and effective. The process of getting FDA approval for a new drug can take as little as one year or up to a decade, according to Michael Anisfeld, president of Globepharm, a consulting fi rm for healthcare manufacturers. The FDA has a two-tier system for new drug review. The standard review is for a drug that offers, at most, only minor improvement over existing marketed therapies, and the goal is to get it reviewed within 10 months. Priority designation is applied to drugs that offer major advances in treatment or provide a treatment where none existed previously. The goal for completing a Prior- ity Review is six months. Other approaches, including Fast Track, Breakthrough Therapy and Accelerated Approval, were designed to speed the approval of therapeutically important drugs. The key form in the drug approval process—used since 1938—is the New Drug Application, which is submitted by the manufacturer. The application, which contains data gathered during human and animal testing, is reviewed by a team of physicians, statisticians, chemists, pharmacologists and other scientists from the FDA; this team also reviews the proposed labeling of the drug. According to the FDA, the New Drug Application provides enough information for the FDA to determine if the drug is safe and effective, and whether its benefi ts outweigh its risks; whether the drug's labeling, including its package insert, is appropriate; and whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality and purity. "The documentation required in a New Drug Applica- tion is supposed to tell the drug's whole story, including what happened during the clinical tests; what the ingredi- ents of the drug are; the results of the animal studies; how the drug behaves in the body; and how it is manufactured, processed and packaged," according to the FDA. Generic Drug Approvals Generic drugs are subject to an Abbreviated New Drug Application. The abbreviated application does not require preclinical or clinical data to establish safety and effectiveness. Instead, an application for a generic drug must scientifi cally demonstrate that the product is bioequivalent to the innovator drug. The FDA reports that one way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volun- teers. This gives them the rate of absorption, or bioavail- ability, of the generic drug, which is then compared to the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's blood- stream in the same amount of time as the innovator drug. Federal law allows brand name companies to apply for up to fi ve additional years of patent protection for the new medicines they develop to make up for time lost while their products were going through the FDA approval process. Brand name drugs are subject to the same bioequivalence tests as generics upon reformulation. The FDA reviews active ingredients in over-the- counter drugs, but not the individual products. © GETTY IMAGES 56 SEPTEMBER 2014 | Med Esthetics SAFE & EFFECTIVE continued on page 75