The cost of some pharmaceutical medicines can be financially crippling, particularly during the interval where a particular medication is solely available a brand-name product. This is not necessarily gouging on the part of big pharmabiz. New drugs are expensive and time-consuming to develop, the process costing as much as $2.6 billion in some cases over a development process taking as long 14 years in some instances. The regulations governing the drug-development process are designed to ensure drug safety and efficacy through rigorous regulatory approval protocols, but they do drive up the cost of new drugs substantially through the initial protected market amortization period.
After the that 20-year umbrella of patent protection expires, products chemically and actively similar to brand-name products may be reproduced as generics, opening up market competition and providing greater access to medications at lower costs for individuals and insurers.
The U.S. Food and Drug Administration (FDA) defines a generic drug is a chemical clone of an original drug product sold under a brand name. There are generic versions of both prescription and OTC medicines. For example, ibuprofen is the generic name of the anti-inflammatory drug sold under the brand names Motrin or Advil. The agency observes that biggest difference between a generic drug and a brand-name drug is usually its price, with the generic version typically costing about 30 percent less than the brand-name drug, and noting that widespread use of generics helps control medical costs and insurance premiums.
In order to ensure that generic drugs are therapeutically equivalent to their brand-name counterparts in terms of efficacy in their clinical effects, the U.S. Food and Drug Administration (FDA) requires rigorous testing of generic products and thoroughgoing application processes for manufacturers, the agency noting that prior to government regulatory and approval oversight, prescribing and taking drugs was a risky business for both doctor and patient. Little was known about drugs, no scientific standards existed, and sometimes medicines caused illnesses rather than curing or preventing them. Today, the U.S. drug review process assures that drugs are safe and effective.
The FDA has recently awarded Srinath Palakurthi Ph.D. , Associate Professor of Pharmaceutical Sciences and Director of Graduate Studies at the Texas A&M Rangel College of Pharmacy at Kingsville, Texas, a $250,000 grant to support his development of a test method for determining the therapeutic equivalency of topical eye medications.
“Currently there is a lack of predictive assays for drug release for topical ophthalmic emulsions and suspensions,” Dr. Palakurthi comments in a TAMU release. “It is critical to develop an appropriate drug release method that can help compare and contrast eye products and also predict the drug release in the eye. Such a quality control test would guide the product development process and accelerate the product approval of ophthalmic formulations.”
The FDA grant to Dr. Palakurthi was awarded through the agency’s Center for Drug Evaluation Research (CDER), which is tasked with regulating both over-the-counter and prescription pharmaceuticals, including biological therapeutics and generic drugs, to ensure the safety and effectiveness of medications made available to Americans and others.
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the drug company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug will be approved for sale. The CDER doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety, and effectiveness standards.
The TAMU release also notes that Dr. Palakurthi will be focusing his efforts over the coming year on developing the new test method, which it is hoped will result in a model for scientific validation of future generic topical ophthalmic products, and that his objective is creation of a test protocol tailored specifically for eye products for which patents king them eligible for bringing generic formulations to market.
(Image courtesy Texas A&M University)
Texas A&M University
FDA Center for Drug Evaluation Research
Texas A&M University