WSJ: Watchdog Says FDA Risked Integrity

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.

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

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

GAO: FDA Fails to Inspect Foreign Drug Plants Sufficiently

US General Accountability Office writes a scathing report on the FDA’s failure to inspect foreign drug manufacturing facilities.

Ed Silverman in Pharmalot blogs about the US General Accountability Office recent report which has determined that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities.

According to the Pharmalot post:

• The GAO writes that it is unclear if steps being taken by FDA “will prove successful” and there is an “urgent need” to better protect public health by putting GAO suggestions into practice.

• Here are some key findings:

o The FDA boosted its budget for foreign inspections to $41 million in fiscal 2009 compared with $12 million in fiscal 2008 and $10 million in fiscal 2007, and increased the number of foreign inspections.
o In fiscal year 2009, for instance, the FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively.

• The GAO examined a list the agency kept to prioritize foreign inspections and estimated only 11 percent of the facilities were completed in fiscal year 2009.

• “At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once.” That same year, 1,015 domestic inspections were made, or about 40 percent of domestic facilities.

• The FDA did not know how many foreign drug establishments were subject to inspection, because of inaccurate info in agency database. There were 3,765 facilities in the FDA databases, but 2,394 may never had been inspected. Most of these, not surprisingly, are located in China and India.

• The FDA continues to emphasize inspections of establishments listed on applications for a new drug, instead of those already producing drugs for US consumption. The FDA’s approach is “inconsistent” with the GAO’s 2008 recommendation that the FDA inspect plants, “at a comparable frequency,” that are identified as posing the greatest public health, regardless whether these are foreign or domestic, if there is a manufacturing problem.

• The US Department of Health and Human Services acknowledged the need for improvement, but cites obstacles toward progress, such as the need to obtain permission from the foreign government of the country in which an establishment is located in order to conduct an inspection.

Clearly this report is very troubling to the average health care consumer given the proliferation of raw material contamination's, recalls due to poor manufacturing process, adulteration, fraud and a myriad of other issues that plague our pharmaceutical supply chain.

Historically pharmaceutical companies are outsourcing more of their raw materials, production and packaging than ever before and the FDA does not have the capacity or ability to identify all of the manufacturing plants are that produce the drugs that are taken every day by US consumers.

Along with more robust inspections, it is incumbent upon all members of the supply chain to take measures to make absolutely certain that the products of their brand or the products they distribute or dispense are safe and efficacious.

Secure Pharma Chain encourages all members of the pharmaceutical supply chain to implement a variety of solutions and technologies to test and authenticate the products within their inventories to protect their brand and most importantly the consumer.

To read the entire Phamalot post, visit: http://www.pharmalot.com/2010/11/fda-fails-to-inspect-foreign-plants-sufficiently-gao/#more-27487

To learn more about pharmaceutical verification technologies, visit: http://www.xstreamsystems.net/.