Cath Lab Digest

T oday's media is replete with stories of litigation involving pharmaceutical company maintenance of patents on brand-name drugs. Like other new products, new drugs are developed under U.S. patent protection - a legal structure that gives a company the sole right to sell a drug while the patent is pending (eg, in effect). After an investment of up to 15 years of research and development and millions (sometimes billions) of dollars spent conducting stringently regulated clinical trials, pharmaceutical companies understandably are eager to recoup their investments in the drug through protection and maintenance of its patent.

Once a patent expires, competitive manufacturers are free to apply to the Federal Drug Administration (FDA) to sell generic versions of the branded product. This process does not require the generic product manufacturer to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness for the branded product. Therefore, up-front development costs for the generic product are usually substantially lower than they were for the expensive testing required by the FDA previously completed by the original manufacturer.

Unlike a generic ostomy product, a generic drug is identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance, characteristics, and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

Because medical devices (such as ostomy supplies) and drugs are regulated by different centers within the FDA, their paths to the marketplace are quite different. Medical devices are subject to much less stringent regulations than drugs and are classified according to the degree of regulation needed to provide reasonable assurance of the device's safety and effectiveness and the risk it presents to the user and the patient. Class I medical devices include devices with the lowest risk and Class III includes those with the greatest risk.

Ostomy supplies and accessories are Class I medical devices and subject to the fewest regulatory controls, which could include registration of the establishment where the device is manufactured, adherence to the FDA's Good Manufacturing Practices (GMP), labeling requirements, and prohibitions against misbranding and adulteration. The FDA does not require evidence of safety and effectiveness before an ostomy product can be marketed. In fact, a substantial percentage of all Class I devices may be marketed without any prior filing with the FDA whatsoever. Clinicians must not assume that ostomy products have been clinically tested for safety and effectiveness before they are marketed. However, some manufacturers conduct such studies and make them available to clinicians and consumers to support their product claims, but the government does not require it.¹

Typically, large manufacturers have a quality manufacturing system in place that exceeds the FDA's medical device Quality Systems Requirements (QSR). Small manufacturers may or may not have such a system. If one exists, it is usually a proportionally simpler system, so small manufacturers may not need the same amount of documentation as a large manufacturer to meet Class I medical device FDA requirements. Each bit of documentation, research, regulation, or clinical trial adds cost to a product.