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1 1 (December 4, 2019)

handle is hein.crs/govbbtx0001 and id is 1 raw text is: - .......... December 4, 2019 Medical Product Innovation and Regulation: Benefits and Risks Prior to being marketed in the United States, medical products are reviewed for safety and effectiveness, among other things, by the Food and Drug Administration (FDA). Medical products regulated by FDA include prescription drugs, medical devices, and biologics. When evaluating a product, FDA weighs the potential benefits of a medical product against the potential for certain harms associated with the use of that same product. It is in this context that Congress and FDA have established both premarket and postmarket requirements for medical products, as well as expedited development and review pathways for certain medical products for serious diseases with few available treatment options. In establishing these expedited pathways, Congress and FDA have acknowledged an implicit trade- off between reducing time to marketing and a potentially less complete safety profile upon approval. History \of Medical Product Reguflation, The Biologics Control Act of 1902 (P.L. 57-244) was the first attempt to regulate a pharmaceutical product at the national level. It was also the first premarket approval statute, in contrast to a retrospective postmarket product evaluation. The act focused on the manufacturing process and required that manufacturing facilities be inspected before a federal license was issued to market the biologic. The regulation of drugs began with the Pure Food and Drugs Act of 1906 (P.L. 59-384). The 1906 law did not involve premarket control over new drugs to ensure safety and did not include inspections or any other regulation of manufacturing facilities. Rather, the law focused on the drug label, which could not be false or misleading, and required that the presence and amount of certain dangerous ingredients (e.g., alcohol, cocaine) be listed. In addition, it defined adulterated with reference to the U.S. Pharmacopoeia and National Formulary standards for purity, quality, and strength. It prohibited the introduction into interstate commerce of misbranded or adulterated drugs and food. In 1938, Congress replaced the Pure Food and Drugs Act with the Federal Food, Drug, and Cosmetic Act (FFDCA). The FFDCA required that drug manufacturers submit, prior to marketing, a new drug application (NDA) demonstrating, among other things, that the product was safe. In addition, the FFDCA expanded the prohibition of the introduction into interstate commerce of misbranded or adulterated products to include therapeutic devices and cosmetics. The FFDCA also included some controls over manufacturing establishments, including an authority to inspect such facilities. In 1962, Congress passed the Kefauver-Harris Drug Amendments to the FFDCA (P.L. 87-781), which required that manufacturers provide substantial evidence of drug effectiveness, in addition to safety. The Medical Device Amendments of 1976 (MDA, P.L. 94- 295) was the first major legislation enacted to address the premarket review of medical devices, and it included a number of postmarket requirements as well (e.g., current good manufacturing practices, or CGMPs). The MDA established a risk-based method for classifying and regulating medical devices, and established two premarket regulatory pathways: premarket approval (PMA) and premarket notification (5 10(k)). Speeding Access to Medica Products Over the years, Congress and FDA have made modifications to the established standard premarket review pathways in an attempt to improve access to medical products that would meet a compelling unmet need. The aim of congressional reforms to FDA's review process has primarily been to speed medical product entry to market. These changes are often described as benefiting patients by allowing an innovative drug or device to be more rapidly available in a potentially dire situation for the patient. On the other hand, the less fully regulators explore the safety and effectiveness of medical products before marketing relative to standard review, the higher the odds of unidentified adverse events. The appropriate balance between this risk of unidentified adverse effects and having faster access to beneficial new drugs and devices-and therefore the ideal degree of scrutiny of their safety and effectiveness prior to their marketing-is and will continue to be a matter of debate. Broadly, in an effort to improve access to medical products for serious or life-threatening diseases with limited treatment options, FDA and Congress have established mechanisms to (1) expand access to drugs and devices that are still under investigation, and (2) expedite the actual premarket development and review processes for new products coming onto the market. As used in the following sections, the term drugs generally includes biologics. Inrvesti , gationa M edJi cali Prok Cdu ct.s In general, a drug or device may be provided to patients only if FDA has cleared or approved its marketing application or authorized its use in a clinical trial under an investigational new drug (IND) or investigational device exemption (IDE) application. In certain circumstances, patients may be able to obtain access to investigational drugs and devices outside this framework through expanded access (compassionate use) programs. In 1987, FDA issued a rule creating procedures through which patients could request permission from FDA to obtain an investigational drug outside a clinical trial (treatment IND program; 52 Federal Register 19466). This pathway was codified in the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115) and expanded to include investigational devices. In the E 1 10 NLI,

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