MARK MORRIS
The Kansas City Star
More than a decade after his chemotherapy dilutions shocked the nation, a former Kansas City pharmacist's criminal legacy re-emerged Thursday as Congress considered how to make customized medications safer.
U.S. Sen. Pat Roberts, again looking for ways to regulate what he calls the "bad actors" who work at the fringes of legitimate pharmacy compounding, told a Senate committee that Robert Courtney's dilutions still drive his concern on the issue.
"This is an issue that hit far too close to home in Kansas," Roberts told members of the Senate's Health, Education, Labor and Pensions Committee. "Several years ago a pharmacist in Kansas City was found to be diluting cancer drugs for his patients. Unfortunately, over 4,000 patients were affected before authorities could stop him."
Congress held two days of hearings on pharmacy compounding this week, driven by a meningitis outbreak caused by contaminated steroid injections prepared by the New England Compounding Center in Framingham, Mass. Thus far, more than 30 people have died in 19 states, and 461 others have become ill, according to the Centers for Disease Control and Prevention.
At Wednesday's hearing, before a committee in the U.S. House, the co-founder of that Massachusetts pharmacy refused to discuss his firm's role in the meningitis outbreak, citing his Fifth Amendment right against self-incrimination.
Compounded medications are not the brand-name prescription drugs that people routinely buy at chain drugstores. Instead they are customized medications, often mixed in independent pharmacies without the same safety procedures followed by big drug makers.
Courtney currently is serving a 30-year sentence in federal prison.
The issues that drove senators to organize their initial hearing on pharmacy compounding in 2003 -- first outlined in a three-part Kansas City Star series in October 2002 -- remain vital today. The compounding industry is regulated by a patchwork of state boards of pharmacies. The U.S. Food and Drug Administration argues that it is hamstrung by a lack of jurisdiction.
And some pharmacies produce huge quantities of drugs, mimicking highly regulated pharmaceutical manufacturers, but with few of the safeguards.
In an interview after the hearing Thursday, Roberts appeared buoyed by what he had heard. Senators peppered witnesses from government and industry with questions about what they all could do to clarify a haphazard regulatory system that has allowed too many contaminated drugs to injure and kill patients.
"I worry about regulations, particularly with this administration," said Roberts, a Republican. "But ... we've been treading water for more than a decade. Now we're on the spot. We have to come up with something."
By contrast, Roberts' concerns were taken less seriously by some of his colleagues at the 2003 hearing, which he organized with then-Missouri Sen. Kit Bond.
At that hearing, then-Nevada Sen. John Ensign criticized FDA testimony and suggested that a more robust federal regulatory system would "strangle" pharmacy practice.
Sarah Sellers, a pharmacist and drug safety advocate who also testified at the 2003 hearing, watched Thursday's session over the Internet from her home in Illinois and also noted both the change in tone and the new sense of urgency.
"The words of Senator Roberts give me hope," she said. "He was calling on all parties to make this happen so these patients will not have died in vain."
Even a representative of the International Academy of Compounding Pharmacists, which often has opposed more stringent regulation of its members, pledged "absolutely" to work with senators, though the academy still opposed sweeping new laws to cover the industry.
Roberts, who said he has weathered industry "pushback" before, said his goals remained relatively simple: To leave legitimate compounding in the hands of pharmacists who are filling a doctor's prescription for an individual patient, while clarifying the way to shut down large-scale manufacturers who mass produce drugs without FDA approval.
He said he never imagined that it would take this long.
"This has been an ongoing thing," Roberts said. "It's such a terrible, terrible shame to finally get things refocused as a result of 30 deaths."
Source round here
U.S. Sen. Pat Roberts, again looking for ways to regulate what he calls the "bad actors" who work at the fringes of legitimate pharmacy compounding, told a Senate committee that Robert Courtney's dilutions still drive his concern on the issue.
"This is an issue that hit far too close to home in Kansas," Roberts told members of the Senate's Health, Education, Labor and Pensions Committee. "Several years ago a pharmacist in Kansas City was found to be diluting cancer drugs for his patients. Unfortunately, over 4,000 patients were affected before authorities could stop him."
Congress held two days of hearings on pharmacy compounding this week, driven by a meningitis outbreak caused by contaminated steroid injections prepared by the New England Compounding Center in Framingham, Mass. Thus far, more than 30 people have died in 19 states, and 461 others have become ill, according to the Centers for Disease Control and Prevention.
At Wednesday's hearing, before a committee in the U.S. House, the co-founder of that Massachusetts pharmacy refused to discuss his firm's role in the meningitis outbreak, citing his Fifth Amendment right against self-incrimination.
Compounded medications are not the brand-name prescription drugs that people routinely buy at chain drugstores. Instead they are customized medications, often mixed in independent pharmacies without the same safety procedures followed by big drug makers.
Courtney currently is serving a 30-year sentence in federal prison.
The issues that drove senators to organize their initial hearing on pharmacy compounding in 2003 -- first outlined in a three-part Kansas City Star series in October 2002 -- remain vital today. The compounding industry is regulated by a patchwork of state boards of pharmacies. The U.S. Food and Drug Administration argues that it is hamstrung by a lack of jurisdiction.
And some pharmacies produce huge quantities of drugs, mimicking highly regulated pharmaceutical manufacturers, but with few of the safeguards.
In an interview after the hearing Thursday, Roberts appeared buoyed by what he had heard. Senators peppered witnesses from government and industry with questions about what they all could do to clarify a haphazard regulatory system that has allowed too many contaminated drugs to injure and kill patients.
"I worry about regulations, particularly with this administration," said Roberts, a Republican. "But ... we've been treading water for more than a decade. Now we're on the spot. We have to come up with something."
By contrast, Roberts' concerns were taken less seriously by some of his colleagues at the 2003 hearing, which he organized with then-Missouri Sen. Kit Bond.
At that hearing, then-Nevada Sen. John Ensign criticized FDA testimony and suggested that a more robust federal regulatory system would "strangle" pharmacy practice.
Sarah Sellers, a pharmacist and drug safety advocate who also testified at the 2003 hearing, watched Thursday's session over the Internet from her home in Illinois and also noted both the change in tone and the new sense of urgency.
"The words of Senator Roberts give me hope," she said. "He was calling on all parties to make this happen so these patients will not have died in vain."
Even a representative of the International Academy of Compounding Pharmacists, which often has opposed more stringent regulation of its members, pledged "absolutely" to work with senators, though the academy still opposed sweeping new laws to cover the industry.
Roberts, who said he has weathered industry "pushback" before, said his goals remained relatively simple: To leave legitimate compounding in the hands of pharmacists who are filling a doctor's prescription for an individual patient, while clarifying the way to shut down large-scale manufacturers who mass produce drugs without FDA approval.
He said he never imagined that it would take this long.
"This has been an ongoing thing," Roberts said. "It's such a terrible, terrible shame to finally get things refocused as a result of 30 deaths."
Source round here
No comments:
Post a Comment