Pharmaceutical Research America

Neiv DrugApprovals in 1994, Pharmaceutical Research and Manufacturers of America, Washington, D.C., 1995. 

A guideline for evaluation of the photostability of new drug substances and dosage forms was published in 1997 [39]. Subsequently, a joint study was undertaken by the U.S. Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America to evaluate the ICF1 guideline. A draft chapter for the United States Pharmacopeia, based on the guideline and the joint study, has been published in Pharmacopeial Forum [40]. 

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. 

The results of clinical trials conducted under an IND have traditionally been regarded as confidential business information that FDA was prohibited from releasing to the public under the Freedom of Information Act and that the publication of which was determined solely by the drug sponsor. The Food and Drug Administration Modernization Act of 1997 established a clinical trial data bank for drugs for serious or life-threatening disease and required the inclusion of information on all effectiveness trials for these drugs. As a result of widespread concern about the lack of public availability of information about all clinical trials and their results, individual companies and the Pharmaceutical Research and Manufacturers of America have... 

These amounts describe worldwide research and development spending by member companies of the Pharmaceutical Research and Manufacturers of America and are expressed in constant 2002 dollars using the National Institutes of Health Biomedical R D Price Deflator. See Cockburn (2004), p. 11. 

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). 

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