FDA approval process

Some sort of revenue-sharing arrangement if and when the compound reaches the market out-licensed revenues.) The variable revenues per out-licensed compound is commonly a time-based scenario of revenue generation over the life of the compound before it eventually exits through the retirement flow. A proper analysis of the revenues per out-licensed compound flow should incorporate the uncertainty of markef enfry however, if fhe out-licensed NCE is one which has not yet passed the FDA approval process. 

Thus, Hatch-Waxman balanced an expedited FDA approval process to speed generic entry with patent term restoration to... 

U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPROVAL PROCESS FOR DRUGS... 

The ffatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act, makes it easier for generic drugs to get approval from the FDA but also allows drug companies to extend their patents when the FDA approval process delays the sales of patented drugs. 

Not all drugs proceed through the FDA approval process in the same fashion. Alternative approval processes apply to INDs that treat serious or life-threatening conditions, especially conditions that have no satisfactory alternative treatment. 

Phase trials and the FDA approval process often require seven to eight years. Raloxifene (2.28) (Figure 2.12) was initially approved to treat osteoporosis. After being on the market for several years, raloxifene was reported to be an effective treatment for certain forms of breast cancer. Estimate how much time would be required for clinical trials and approval of raloxifene as a breast cancer treatment. Justify your answer. 

An unpublished document obtained during discovery in product liability suits against the drug company disclosed that Eli Lilly, the manufacturer of fluoxetine (Prozac), had evaluated the comparative rates of suicide attempts on fluoxetine, amitriptyline, and placebo (the documents are available from http //www.breggin.com). The data were generated during controlled clinical trials conducted for the FDA approval process for Prozac for depression. On the basis of the company s data for controlled clinical trials, patients taking fluoxetine were 12 times more... 

Kirsch et al. obtained 47 studies, an average of almost eight per drug, conducted as a part of the FDA approval process. After examining all of the studies, they found that any beneficial or positive effects in comparison to placebo were negligible. 

The FDA approval process is about creating and obtaining a label for the marketing of the drug. The approval of the label by the FDA is the final step in the process before the government allows the drug to go to market. 

The gap between drug company claims and reality can be enormous in regard to the numbers of patients tested. Eli Lilly, for example, gave the impression that between 6,000 and 11,000 patients had been given Prozac during the FDA approval process. When I laboriously reviewed each of the Prozac studies that the FDA considered valid enough to use for approval, I discovered that a total of only 286 patients had completed them (Breggin et al., 1994). 

Sertindole is another atypical neuroleptic currently going through the FDA approval process. 

Alternatively, if the research isn t going well or the FDA approval process seems too onerous, companies can forget about novel approaches altogether. They can just fiddle with what s already on the market, maybe churning out a marginal improvement to a hot blockbuster. 

In the United States, the 20-year term (9) of a patent is measured from its earliest nonprovisional filing date for which benefit is claimed. Largely because of the time involved in the FDA approval process and associated clinical trials, a considerable portion of the patent term can elapse before a patented drug can be sold in the marketplace. Thus, the period effectively available for the drug developer to recoup its investment and earn a profit can be considerably shorter than the 20-year patent term. 

---