boutons_
04-07-2006, 10:51 AM
Of course, it's the consumers who get fucked.
FDA Won't Release Generic Insulin Guide
By ANDREW BRIDGES
The Associated Press
Thursday, April 6, 2006; 8:18 PM
WASHINGTON -- The Food and Drug Administration will not release long-delayed guidelines specifically for the production of generic versions of insulin and human growth hormone, according to an agency letter.
The guidelines, in draft form since 2002, would help manufacturers seeking to produce generic versions of insulin and human growth hormone. It is estimated that $3.5 billion is spent on the two drugs each year; introduction of those lower-cost versions could reduce that total by hundreds of millions of dollars.
The FDA long had suggested the guidelines were forthcoming. But the agency, in a reply to a Feb. 10 letter by Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., said it now intends to publish broader guidelines that apply to all generic versions of protein-based drugs, also known as follow-on protein products.
Waxman said the reply by associate commissioner for legislation Patrick Ronan left him "extremely disappointed." He and Hatch say insulin and growth hormone should be considered separately, given their simple structures and long history of safe use.
Waxman said in a statement that the FDA's action was "a misguided step that will only result in further delay" of rules for low-cost generics.
The guidance would spell out requirements for drug makers before they could win approval of generic versions of insulin and growth hormone, presumably at reduced prices, without repeating the expensive human trials originally mandated for brand-name versions.
With traditional chemical drugs, companies simply have to show that a generic version works the same way as a brand-name original to gain FDA approval.
The FDA first announced in 2001 that it was working on the guidelines to produce generic versions of insulin, widely used by the growing ranks of diabetics, and human growth hormone, used to treat growth deficiencies and other conditions.
The FDA's letter of reconsideration was obtained Thursday by The Associated Press. The disclosure comes days after the FDA published a brief analysis that showed the availability of just two generic versions of a brand-name drug can cut in half the price consumers pay for that medicine.
Unlike chemical drugs, biotech drugs _ also called biopharmaceuticals or biologics _ are based on proteins derived from living cells. They account for a growing percentage of Medicare and Medicaid costs, according to the Generic Pharmaceutical Association, which supports the guidelines' release.
The Hatch-Waxman Act of 1984 helped spawn the generic drug industry.
© 2006 The Associated Press
FDA Won't Release Generic Insulin Guide
By ANDREW BRIDGES
The Associated Press
Thursday, April 6, 2006; 8:18 PM
WASHINGTON -- The Food and Drug Administration will not release long-delayed guidelines specifically for the production of generic versions of insulin and human growth hormone, according to an agency letter.
The guidelines, in draft form since 2002, would help manufacturers seeking to produce generic versions of insulin and human growth hormone. It is estimated that $3.5 billion is spent on the two drugs each year; introduction of those lower-cost versions could reduce that total by hundreds of millions of dollars.
The FDA long had suggested the guidelines were forthcoming. But the agency, in a reply to a Feb. 10 letter by Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., said it now intends to publish broader guidelines that apply to all generic versions of protein-based drugs, also known as follow-on protein products.
Waxman said the reply by associate commissioner for legislation Patrick Ronan left him "extremely disappointed." He and Hatch say insulin and growth hormone should be considered separately, given their simple structures and long history of safe use.
Waxman said in a statement that the FDA's action was "a misguided step that will only result in further delay" of rules for low-cost generics.
The guidance would spell out requirements for drug makers before they could win approval of generic versions of insulin and growth hormone, presumably at reduced prices, without repeating the expensive human trials originally mandated for brand-name versions.
With traditional chemical drugs, companies simply have to show that a generic version works the same way as a brand-name original to gain FDA approval.
The FDA first announced in 2001 that it was working on the guidelines to produce generic versions of insulin, widely used by the growing ranks of diabetics, and human growth hormone, used to treat growth deficiencies and other conditions.
The FDA's letter of reconsideration was obtained Thursday by The Associated Press. The disclosure comes days after the FDA published a brief analysis that showed the availability of just two generic versions of a brand-name drug can cut in half the price consumers pay for that medicine.
Unlike chemical drugs, biotech drugs _ also called biopharmaceuticals or biologics _ are based on proteins derived from living cells. They account for a growing percentage of Medicare and Medicaid costs, according to the Generic Pharmaceutical Association, which supports the guidelines' release.
The Hatch-Waxman Act of 1984 helped spawn the generic drug industry.
© 2006 The Associated Press