PhRMA Manufacturers

PhRMA is a trade association of over 100 research-based pharmaceutical companies. For membership a company must manufacture and market finished dosage-form products under its own brand names and must conduct a significant amount of research and development in the United States. 

Pfizer Specialty Chemical Group, 243 Pharmaceutical Research and Manufacturers of America (PhRMA), 272 Pharmacia Coi"poration, 243 Phelps Dodge Coi"poration, 243... 

There are six parties directly involved in ICH as well as observers and the International Federation of Pharmaceufical Manufacturers Association (IFPMA see Table 25.1). The six parties are the founder members of ICH, and fhey represenf fhe regulatory bodies and the research-based industry in the European Union (EU), Japan, and the United States in the EU, the European Federation of Pharmaceufical Indusfries and Associations (EFPIA) and the Ministry of Healfh, Labour, and Welfare (MHLW) in Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) and in the United States, the FDA and the Pharmaceutical Researchers and Manufacturers of America (PhRMA). 

Sources. (1) PhRMA (Pharmaceutical Research and Manufacturers of America) Press Release dated November 14, 2006. http //www.who.int/mediacentre/factsheets/fs310/en/ index.html [accessed April 19, 2007], (2) CNN.com. Largest Passenger Jet Unveiled, January 18,2005. http //www.cnn.eom/2005/BUSINESS/01/18/airbus.380/ [accessed April 19, 2007], (3) Tufts Center for the Study of Drug Development, http //www.bizjournals.com/ sanfrancisco/stories/2006/12/04/newscolumn3.html [accessed September 26,2007]. 

Figure 1.2 R D investments by research-based US pharmaceutical companies. Source. The Pharmaceutical Research and Manufacturers of America (PhRMA). Pharmaceutical Industry Profile 2006. http //www.phrma.org/files/2006%20Indusry%20 Profile.pdf, and http //www.phrma.org/news room/press releases/r%26d spending by u.s. biopharmaceutical companies reaches a record %2455.2 billion in 2006/ [accessed July 7, 2007].

Further examples of R D investments into drug research by research-based US pharmaceutical companies from 1980 to 2006 are shown in Fig. 1.2. The enormous spending on R D has escalated in recent years. According to reports by The Pharmaceutical Research and Manufacturers of America (PhRMA), US pharmaceutical companies have almost doubled their R D spending every five years since 1980. Out of every five dollars earned in sales, a dollar is put back into R D. In 2006 the US pharmaceutical industry spent 55.2 billion to develop new drugs. 

The main players at ICH are now the European Commission/EMEA, EEPIA, Japanese Ministry of Health Labour and Welfare (MHLW), Japanese Pharmaceutical Manufacturers Association (JPMA), US FDA and Pharmaceutical Research and Manufacturers of America (PhRMA). The WHO, Canadian Health Protection Branch and the European Free Trade Area (BETA) countries enjoy an observer status at ICH meetings. 

Gahart et al. (2003) recently the U.S. Pharmaceutical Research and Manufacturers of America issued guideline principles for its members regarding DTCA see PhRMA (2005). For a discussion of policy debates in New Zealand, and a comparison of the United States and New Zealand controversies, see Hoek, Gendall, and Calfee (2004). 

Pharmaceutical Research and Manufacturers of America. 2005. PhRMA Guiding Principles Direct to Consumer Advertisements about Prescription Medicines. Washington, DC, August 2005. AvaUahle at www.phrma.org. 

Executive Committee of the Pharmaceutical Research and Manufacturers of American (PhRMA), PhRMA Code on Interactions with Healthcare Professionals, July 1,2002. Available online at http //www.phrma.org... 

Pharmaceutical Research and Manufacturers of America (PhRMA) The association s sixty-seven member companies are involved in the discovery, development, and manufacture of prescription drugs. Additionally, twenty-four research affiliate companies conduct research related to the development of biopharmaceuticals and vaccines. PhRMA, previously known as the Pharmaceutical Manufactures Association (PMA), provides its technical input to ICH. 

Bjornsson TD, Callaghan JT, Einolf HJ, et al. The conduct of in vitro and in vivo drug-drug interaction studies a Pharmaceutical Research and Manufacturers of America (PhRMA) perspective. Drug Metab Dispos 2003 31(7) 815-832 J Clin Pharmacol 2003 43(5) 443 69. 

Pharmaceutical Research and Manufacturers Association-Quick Facts (http // www.phrma. org/publications/quickfacts /14.08.2001.278.cfm). 

The PhRMA Environmental Monitoring Work Group published an article in the March 1997 issue of Pharmaceutical Technology on microbiological monitoring of environmental conditions for nonsterile manufacturing [4]. This publication is a compilation of survey results of nonsterile manufacturing facilities within the United States and recommendations based on the survey results. In this section, a summary of the survey results and recommendations pubhshed in this article are reviewed with a few comments from this author based on experiences in this area. 

Pharmaceutical Research and Manufacturers Association of America (PhRMA) (1997, March), Microbiological monitoring of environmental conditions for nonsterile manufacturing, Pharm. Technol., 58-74. 

PhRMA, What Goes into the Cost of Prescription Drugs Washington, D.C. Pharmaceutical Research and Manufacturers of America, 2005. Also available online. URL http //www.phrma.org/files/Cost of Prescription Drugs.pdf. Downloaded April 4, 2009. 

The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing companies that make more than 75 percent of brand-name drugs in the United States, sued the state of Maine over the validity of the Maine Rx Program. It moved for a preliminary injunction to stop implementation of the law until the court could hear its suit. The district court approved the preliminary injunction and later ruled in favor of... 

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