Posted by James
Don’t let the tux fool you. Dr. Goldenberg, or “Marvelous Marvin,” as I sometimes call him, is actually a very down-to-earth person, comfortable in jeans and sneakers.
On the weekends, in nice weather, you can find him at the local crafts fairs from New York to Pennsylvania, selling his handmade pottery. He is partial to cool blue and green glazes on his bowls, mugs, vases, and other creations. He’s a veritable pottery machine.
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Posted by James
The latest generic drug legislation, the Gregg-Schumer amendment (also known as GAAP) would achieve savings comparable to those of the original Schumer-McCain legislation of 2002 but would use a different approach to modify the patent laws. The key elements of the Gregg-Schumer proposal are described next.
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Posted by James
Several assumptions were made regarding the Hatch-Wax-man Act:
Duplicates of generic drugs will be the same as the innovator’s drug in terms of chemical composition. The FDA still uses the plus-or-minus 20% test to determine blood serum bioavailability (i.e., the amount of active ingredient in the blood over a period of time must come within plus-or-minus 20% of that which is observed when the innovator’s drug is ingested). Twenty percent is a fairly good margin, and many medical professionals believe that for drugs with a wide index of tolerance, 20% is not important at all; in such instances, twice as much or half as much of the active ingredient in a generic product would still work.
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Posted by James
A Critical View
Title I of the Act (Table 1), which addressed drug price competition, specifically authorized Abbreviated New Drug Applications (ANDAs) and prohibited the FDA from asking for more than bioavailability studies for approval. In that regard, this piece of legislation was unique because it tied the hands of a regulatory agency in the area of public health by specifying that the FDA could require bioavailability studies only for ANDAs. In contrast, five-year data exclusivity for new molecular entities (NMEs) provided for a period of exclusivity such that once an NME was approved, a generic version could not be approved for five years (Table 2). The Act also called for a three-year data exclusivity period for supplements requiring clinical trials.
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Posted by James
The high cost of prescription drugs in the U.S. today is of major concern to many segments of the population, especially the large number of older adults. Because expenditures on medications have risen sharply during the past two decades, Congress has been under great pressure from the elderly and other consumer groups to control drug prices. However, price controls would reduce the number of new drugs introduced into the market; prices are high partly because research and development (R&D) is very expensive.
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Posted by James
Speaker: Matthew K. Ito, PharmD, Professor and Vice Chair, Pharmacy Practice Department, Thomas J. Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, California.
Dyslipidemia is a common side effect of protease inhibitor therapy in HIV-infected patients. An encapsulated form of pravastatin (Pravachol generic) appears to offer a new efficacious therapeutic approach for these patients. This form of the statin brings about significantly greater reductions in total cholesterol, LDL-C, and non-HDL-C levels compared with nonencapsulated pravastatin, and it has a similar safety profile.
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Posted by James
Speaker: Christie Ballantyne, MD, Director of the Center for Cardiovascular Disease Prevention, and Professor of Medicine, Baylor College of Medicine and The Methodist De Bakey Heart Center, Houston, Texas.
In patients with high cholesterol levels, drug ezetimibe (EZE) (Zetia generic) plus simvastatin (Zocor tablet) (both manufactured by Merck/Schering Plough), were given. These two agents, which inhibit both cholesterol synthesis and intestinal absorption, provided significantly greater reductions in LDL-C for a range of doses, compared with atorvastatin (Lipitor generic) monotherapy in all dosing ranges.
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