GAO criticizes FDA saying that it risked giving the appearance of compromised integrity.
Alicia Mundy in a Wall Street Journal article reports on a Government Accountability Office (GAO) report criticizing the Food and Drug Administration (FDA) for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.
According to the Wall Street Journal article:
• A congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
• Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG's Sandoz unit.
• Also critical of the FDA's actions are Momenta's rivals—including Teva Pharmaceutical Industries Ltd., the world's largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA's generic-drug division. The drug companies' applications are still awaiting FDA action.
• The controversy centers around Momenta's performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company's application to sell the generic version of a blockbuster blood thinner.
• As a result, "agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," including heparin-related drug approvals, the report says,
• In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta's expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.
• The FDA has said its reliance on Momenta's free work had nothing to do with its approval of the company's drug ahead of competitors'.
• Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.
• Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug's sales have topped $300 million.
• Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation . "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said.
• The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.
• The FDA said that Momenta's researchers did an excellent job identifying the contaminant. "This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists," it wrote in a response to the GAO.
• Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency's "fundamental weakness" in dealing with the surge of Chinese medical imports.
Although this article spends most of its time dealing with potential conflict of interest and integrity issues within the FDA, Rep. Barton’s final quote is the most important as it relates to the safety of the domestic pharmaceutical supply chain.
Alicia Mundy in a Wall Street Journal article reports on a Government Accountability Office (GAO) report criticizing the Food and Drug Administration (FDA) for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency.
According to the Wall Street Journal article:
• A congressional committee plans to release a report by the Government Accountability Office that says the FDA risked giving the appearance that it had compromised its integrity because of its dealings with the company, Momenta Pharmaceuticals Inc.
• Winning the first right in July to sell the generic version of the blood thinner Lovenox has already meant hundreds of millions of dollars in sales for Momenta and its partner, Novartis AG's Sandoz unit.
• Also critical of the FDA's actions are Momenta's rivals—including Teva Pharmaceutical Industries Ltd., the world's largest generic drug manufacturer, and Amphastar Pharmaceuticals Inc.—as well as a recently retired official in the FDA's generic-drug division. The drug companies' applications are still awaiting FDA action.
• The controversy centers around Momenta's performance of months of free work for the FDA during a high-profile investigation of tainted Chinese drug imports in 2008. At the same time, agency officials were reviewing the company's application to sell the generic version of a blockbuster blood thinner.
• As a result, "agency officials ran the risk of undermining public confidence in the integrity of FDA's operations," including heparin-related drug approvals, the report says,
• In response to the report, requested by Rep. Joe Barton (R., Texas), the FDA said it needed to draw on Momenta's expertise to find the cause of the tainted Chinese imports, but it acknowledged it should have considered potential conflicts of interests and done more to disclose them.
• The FDA has said its reliance on Momenta's free work had nothing to do with its approval of the company's drug ahead of competitors'.
• Momenta said it conducted the investigation for the FDA in the interest of public health, not because of its drug application.
• Since Momenta and Sandoz won FDA approval for their rapid-acting heparin in July, the drug's sales have topped $300 million.
• Richard Adams, a former official in the FDA's generic-drug division who retired this year, agreed with the bias allegation . "Everyone closely involved saw that it was stacked and the whole direction was toward Momenta," he said.
• The FDA turned to Momenta for help in early 2008, when it was trying to figure out what was tainting a widely used older form of heparin. Hundreds of people were suffering severe shock after taking the drug, which was linked to 81 U.S. deaths that year.
• The FDA said that Momenta's researchers did an excellent job identifying the contaminant. "This successful effort to protect public health would not have been possible without the unique expertise and extraordinary efforts of the outside scientists," it wrote in a response to the GAO.
• Rep. Barton criticized the FDA for failing to name the culprit for the tainted heparin and said the report shows the agency's "fundamental weakness" in dealing with the surge of Chinese medical imports.
Although this article spends most of its time dealing with potential conflict of interest and integrity issues within the FDA, Rep. Barton’s final quote is the most important as it relates to the safety of the domestic pharmaceutical supply chain.
Making certain that the health care consumer here in the United States is protected from unsafe and ineffective medications is paramount.
Instead of reports and interagency finger pointing, the United States government needs to figure out who attempted to poison the American consumer and bring them to justice. Without this resolution, it seems clear that these criminal acts will continue.
Members of the pharmaceutical supply chain must take it upon themselves to make certain that their inventories are safe from adulterated, sub-standard, fraudulent and counterfeit medications.
To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?KEYWORDS=heparin
Instead of reports and interagency finger pointing, the United States government needs to figure out who attempted to poison the American consumer and bring them to justice. Without this resolution, it seems clear that these criminal acts will continue.
Members of the pharmaceutical supply chain must take it upon themselves to make certain that their inventories are safe from adulterated, sub-standard, fraudulent and counterfeit medications.
To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748703514904575602781097808598.html?KEYWORDS=heparin
To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.
Posts
No comments:
Post a Comment