Generics promotion

GENERIC AND TRADE NAME PROMOTING AN OPTIMAL RESPONSE... 

FDA, in its continuing attempts to promote the rational evolution of bioequivalency testing, sometimes appears to be caught between a rock and a hard place. Pharmaceutical scientists who have served on or testified before FDA Expert Advisory Committees, that have considered generic bioequivalency problems... 

In this context, policies tending to promote generics basically seek to eliminate or reduce product differentiation and encourage price competition. 

Promotion of generic policy and setting up of the Spanish Pharmaceutical Agency in June 1999, in an attempt to achieve more rational pharmaceutical policies... 

Companies would thus be practising cross-subsidies between products under patent and products whose patent has expired, in order to maintain their overall income. Other strategic responses are patent extension, the creation of second brands and subsidiaries of generics and the differentiation of the brand product through marginal innovations and promotion campaigns. 

A drug whose labeling or promotional materials makes reference to a specific device or generic class of devices ordinarily remains a drug regulated by CDER. It may, however, also be subject to the combination products regulation. 

Hurwitz, M.A. and Caves, R.E., Persuasion or information promotion and the shares of brand name and generic pharmaceuticals, /. Law. Econ., 31, 299-320,1988. 

Schwesingefs phosphazene base 2-tert-butylamino-2-diethylamino-l,3-dimethyl-perhydro-l,3,2-diazaphosphorine (PS-BEMP has a pKb = 27.5 in MeCN) has been immobilized and shown to have immense utility in the N- and O-alkylation of many weakly acidic heterocycles. Kim et al. has made extensive use of this reagent in the multi-step synthesis of a small collection of guanines possessing potential antiviral activity [90]. The generic procedure involved the direct alkylation of the purine moiety (20) (Scheme 2.64), promoted by PS-BEMP, resulting in a mixture... 

The Generic Sales Representatives Examination is appropriate for, and must be taken by, representatives who promote medicines primarily on the basis of price, quality and availability. 

That argument was first famously raised by the then U.S. FDA Commissioner Mark McClellan before the First International Colloquium on Generic Medicine in Cancun, Mexico (September 25, 2003). It was raised again by the Republican Policy Committee of the United States Senate (2005). Its policy statement, Pharmaceutical Price Controls Abroad An Unfair Trade Policy, cited the 2002 U.S. Trade Promotion Authority Act, which acknowledged that price controls and reference pricing for pharmaceutical products (to be discussed below) are trade-distorting... 

Hurwitz, Mark A., and Richard E. Caves. 1988. Persuasion or Information Promotion and the Shares of Brand Name and Generic Pharmaceuticals. Journal of Law and Economics 31, no. 5 299-320. 

Use available and impartial price information Allow price competition in the local market Promote bulk procurement Implement generic policies... 

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