Generic versions of biotechnology drugs are not available, although in 2010 the U.S. developed a reg

Drugs for conditions like allergies and heartburn that required prescriptions in the past are now available for OTC sale. In fact, once six or more generic manufacturers are in the market for a particular drug, that drug can cost 90 percent less than the original branded medication. Generic drugs are usually also much less expensive than branded medications.

Studies show that generic drugs are clinically equivalent to brand-name drugs. Generic drugs contain the same active ingredients, strength, and dosage as the branded drug, and are approved by the FDA as bioequivalent to the brand-name version. Use of generic drugs has also increased in recent years.

However, today the specialty drug designation also applies to new, and highly expensive, drugs available to treat common conditions like hepatitis C as well, thereby having a much larger impact on overall pharmaceutical spending. Health insurance companies such as Blue Cross and Blue Shield outsource the prescription benefit to PBMs to handle all of the details, such as creating the formularies, corresponding co-pay levels and discount and rebate arrangements. In the U.S., the majority of the pharmaceutical wholesaler business is concentrated in a few companies that hold the majority of the market share.

The drugs move from manufacturers to wholesalers, the middlemen that provide the drug to the pharmacy or retailer who sells it to the end user. Once the drug is approved, then begins the marketing process to make the drug available for patients,” Seeley says. The pharmaceutical supply process through which medications travel to patients is multi-faceted, involving a number of stakeholders,” says Elizabeth Seeley, MS, PhD, Adjunct Lecturer in Health Policy and Management at the Harvard T.H. Chan School of Public Health.

In 2007, 40 percent of the worldwide total of approximately 6,500 drugs in clinical development were originated in the U.S. In addition, the authors point out that in recent years the financial commitment made by the National Institutes of Health (NIH) to biomedical research to develop new treatments has been disappointing in scope due to budget cuts, inflationary losses, and increases in development costs. The United States is the worldwide leader in per capita prescription drug spending , representing between 30 and 40 percent of the worldwide market.

For example, the Forum on Drug Development, which looks at ways to improve the pharmaceutical system, has convened workshops on ⢠Emerging Safety Science (April 23, 2007); ⢠The Future of Drug Safety: Challenges for the FDA (March 12, 2007); ⢠Addressing the Barriers to Development in Pediatrics (June 13, 2006); ⢠Understanding the Benefits and Risks of Pharmaceuticals (May 30, 2006); and ⢠Adverse Drug Event Reporting (November 3, 2005).