Drug Laws & Regulations

Drug legislation in recent years has focused on ways to shorten the "drug lag" associated with the stringent regulatory standards that can delay new product introductions. The total elapsed time of a drug product from laboratory to launch can average anywhere from ten to fifteen years. This can make it difficult for a company to recover research costs, as the drug has a shortened shelf life under patent protection guarenteeing exclusive marketing rights to its developer. The public and industry concern over the "drug lag" postponing access to promising new therapies, and a fear of escalating costs to the consumer has led to reforms intended to accelerate the drug approval process. Some goals of these laws are to reduce drug prices, decrease government oversight costs, and to encourage innovative research regardless of the commercial potential of the drug.

Medicare Modernization: The Medicare Prescription Drug Improvement and Modernization Act of 2003
Changes to Medicare Part D (the prescription drug section) have had far-reaching consequences for pharmacists and patients, particularly the elderly. The Centers for Medicare and Medicaid provide assistance to consumers at the Prescription Drug Coverage section of Medicare.gov.

Orphan Drug Act of 1983
Developing a new drug is extremely expensive, especially as an estimated 4 out of 5 products that undergo clinical testing never reach the marketplace. One study estimated the price tag for developing a new molecular entity to be $500 million. Even if a drug has therapeutic merit, that does not guarentee commercial success and a return on the investment. Demographics also play a major role, with some patients with rare diseases or conditions becoming therapeutic "orphans" in the highly competitive, free trade environment. The Orphan Drug Act of 1983 was designed to lessen these problems by providing incentives for manufacturers to develop and market drugs intended to treat or prevent medical conditions that affect fewer than 200,000 people.

The Food and Drug Administration Modernization Act of 1997 (FDAMA)
The Food and Drug Administration Modernization Act, enacted Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. Some highlights of this legislation include: the extension of market exclusivity by six months for new pediatric indications on drugs; authorization of a new mechanism for fast track approval of drugs for serious or life-threatening conditions; the relaxation of restrictions on pharmacy compounding, permitting qualified practitioners to manufacture, on a local level and limited scale, products not commercially available; allows manufacturers to distribute peer- reviewed journal articles on off-label uses, provided that they first agree to file Supplemental New Drug Applications to bring underground practices into the mainstream.

Online Resources

Legal Information Institute: Overview of Food and Drug Law
Cornell University's Legal Information Institute has put together this web site devoted to finding legal information on the web. The section on Food and Drug Law contains hyperlinks to federal and state drug statutes, regulations and decisions.

Food and Drug Adminstration (FDA)
The mission of the FDA is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.

Lexis-Nexis Academic UNC Access ONLY
This database covers general, regional, and international news, company news and financial information, legal information (including law reviews, case law and legal rulings), and other topics such as biographical information. Many of the files are full-text.

RegSource.com
RegSource.com provides regulatory affairs information from agencies such as the US Food and Drug Administration (FDA), European Medicines Evaluation Agency (EMEA), Canada's Health Protection Branch (HPB) and other international regulatory bodies. Some of the information provided are Federal Register notices indexed by subject area, links to regulatory guidance documents, laws and regulations.