Harvard University Medical School

This article is a result of a December 2008 conference at Harvard University, Cambridge, Massachusetts, United States (US), on drug branding. As stated here: "Generics now make up about 65 percent of all prescriptions filled but a mere 10 to 15 percent of national pharmaceutical expenditures. They work as well as their name-brand counterparts and even better in some situations. Yet, despite evidence of their effectiveness, safety, and value, most doctors and patients still prefer the brand-name products."


The conference attendees suggested that there may be a disconnect between science and perception that could be preventing the health care system from realising the full public health potential of generic drugs. The relationship of branded and unbranded, or generic, drugs exists in a historical context of marketing. Originally generics were called "nonproprietary", meaning that they were not manufactured by the company of origin. The rise of patent-protected drugs led to an association of the company name with the quality of the product. According to Professor Jeremy Greene, “In an era of brand ascendancy, manufacturers cast generic prescribing as an act of counterfeiting and undermining of patient safety and physician autonomy.” As US patents expired for many medicines, "drug makers hobbled generic development with patent infringement lawsuits, regulatory challenges, and public marketing campaigns" which were ended by a US Senate subcommittee. In 1984, a new US Food and Drug administration review process for generics was created, resulting, as stated here, in proof that, for the most part, there is an effectiveness equivalency between generic and branded medicine. However, "…a lingering perception of the superior therapeutic value of brands persists in the minds of physicians and consumers."


The article states that there are still ways that drug manufacturers can use patent laws to block or delay the sale of generic drugs. In addition, in a systematic review and meta-analysis of medical journal editorials, more than 50 percent discouraged the use of a generic medicine in treating for a cardiovascular disease symptom. However, one physician felt that, "in general, generic prescriptions promote better long-term adherence to medication and are more likely to be embraced as safe and effective by people with higher incomes and education."


However, global manufacture is bringing in new challenges of drug quality and safety. Other quality issues relate to the new generation of therapeutic proteins, or biologics, produced by biotechnology. The number of sites making drug products outside the United States has more than doubled from 1,200 in 2001 to 2,700 in 2007, while FDA inspections reportedly increased to 325 in the same time period. More resources and legislative authority are needed to address the threats of globalisation to drug safety, according to sources attending the conference.

Harvard Focus Online website on January 23 2009.