Bless those hard-working souls at the FDA... They've been BUSH-WHACKED!
cross-posted at Star City Harbinger
Here's my summary of key lessons learned by watching the live congressional hearing webcast and a re-play later on C-SPAN:
The Heparin Disaster: Chinese Counterfeits and American Failures
110th Congress
Energy and Commerce Committee
Subcommittee on Oversight and Investigations
Hearing -- April 29, 2008
"The Food and Drug Administration is incapable of insuring safety of overseas drug production""Americans ... have to die, before an inspection would occur".
"... often it requires a crisis to compel change" , FDA Inspector Regina Brown
GÇó 11 countries received contaminated heparin from some 12 Chinese sources - indicating a wide-spread, intentional use of contaminated materials.
GÇó This was NOT AN ACCIDENT. It required "malice of forethought". It is now believed that someone in the drug manufacturing supply chain, intentionally used a specific chemical, over-sulfated chondroitin sulfate (OSCS), to avoid detection. Chondroitin sulfate is a very inexpensive product marketed as a dietary supplement here in the United States. The over-sulfating process gives it anticoagulant properties that mimic heparin sodium, but at a much lower production cost. Due to cost difference between heparin and OSCS, $2000/kilogram vs. $20/kilogram, it is likely that the motive was monetary reward. It's all about the MONEY!
FINDINGS OF CONGRESSIONAL INVESTIGATION:
1. FDA Has Abandoned Its Mandatory Pre-approval Inspection Policy. FDA acknowledges that they failed to inspect the Chinese facility, Changzhou SPL, prior to the approval of the Baxter supplemental application in 2004, which changed the source of the active pharmaceutical ingredient (API) for Baxter's heparin sodium products from the SPL Wisconsin plant to the newly constructed operation in China. An FDA inspection in 2004 might have revealed many of the serious deficiencies highlighted in FDA's inspection report of February 2008-a report that ultimately resulted in the issuance of the Warning Letter that effectively blocked exportation to the United States.
2. FDA's Woefully Inadequate Information Technology Systems Resulted in Identification of the Wrong Plant to be Inspected Prior to the Adverse Event
3. FDA Inspection Policy Fails to Assess Relative Risks - none of the criteria employed by FDA during pre-approval inspections involves geographic location, manufacturing complexity, or final product sensitivity. No systematic rationale for choosing which sites to inspect prior to FDA approval.
4. The Role of Corporate Due Diligence Cannot Be Relied Upon. Drug Companies under pressure to be profitable, make trade-off decisions that place higher risks on unsuspecting consumers.
Key Data Points:
FDA Plant Inspections:
US - 2 years between visits
China - 20 visits per year to China for 714 finished drug product plants = 30+ years average time span between visits!
Growth Overseas - 2007 FDA Generic drug approval applications = 459 India and 497 China,
vs. 151 US
FDA Inspection services budget requests for 2009:
$5M for criminal investigation
$0 increased plant inspection
The Bush years - Number of plant sites have increased 200% since 2001, there has been a 35% reduction in the FDA inspection force.
FDA estimate of total China API plants (all raw materials used in drug production) -- 3000 to 7000. But they don't know for sure!
FDA would need around $250 million per year to inspect every foreign drug manufacturer every other year, current 2008 budget is $9 million.
FDA political appointees apparently had no plan to address the ramp up of RESOURCES, AUTHORITY or SCIENTIFIC CAPACITY in response to the explosive growth of pharmaceutical production in China or other countries.
Rep. John Dingell, D-Mich., the chairman of the powerful House Commerce and Energy Committee, said the FDA was "woefully lacking" in personnel, effective policies and will at the highest level in its regulation related to the heparin scandal. "Our citizens can no longer trust that their food, drugs, or medical devices are safe when the FDA says they are," said Dingell in his opening remarks at the hearing.Rep. Bart Stupak, D-Mich., said in his opening statement that while it's " regrettable" the FDA didn't inspect a plant in China where heparin was produced, he said a greater responsibility lies with the drug companies themselves. He said Baxter and the company's Chinese supplier have "failed the American public."
Rep. Michael Burgess, R-Texas, said the contamination problem is "a direct assault on the American public."
"Caveat emptor!" Buyer Beware! Stop, Look, & Think before you buy. Vote to Protect your family and your fellow Americans.
Medscape.com: Heparin Contamination was Deliberate Act to Cut Costs?
Author's note: the term "thuggery" is directly quoted from Rep. Michael Burgess, R-Texas.