WASHINGTON, March 1 (UPI) -- Congress began looking Tuesday at what new powers the Food and Drug Administration might need to do a better job of ensuring the safety of drugs after they are approved and put on the market.
The Senate Committee on Health, Education, Labor and Pensions held hearings after an FDA advisory committee recommended COX-2 drugs -- including Celebrex and Vioxx -- should remain on the market despite clinical evidence they increase the risk of heart attack and stroke.
Sen. Edward Kennedy, D-Mass., the ranking minority member, said he wanted to know, in the case of COX-2 drugs, whether the FDA "may have been too willing on safety issues to protect the pharmaceutical companies rather than the public interest."
The FDA collects user fees from pharmaceutical companies and has sped up the drug-approval process, Kennedy noted, so now most drugs are approved in the United States first.
"Drug safety checks have not kept pace with the speed of drug approvals," he said.
This is an issue with the COX-2 drugs, which showed their more serious side effects in post-approval clinical trials designed to see whether the medications could be used for diseases other than inflammation and pain from arthritis.
FDA's Dr. Sandra Kweder testified that although no amount of study before a drug is approved can ever identify all risks, more can be done to track safety better after FDA approval.
The agency is establishing an independent Office of Drug Safety, but Kennedy wanted to know whether the FDA also needed additional enforcement power.
Kweder said her agency was concerned about COX-2 side effects since the first application came in, and after initial clinical-trial data arrived in 2000 showing problems with Vioxx by Merck, it moved to add warnings to that product label.
The problem, Kweder said, "was the delay that it took to get that information into the labeling -- it took over a year."
Changing product-label language requires negotiations between FDA and the pharmaceutical company.
"We don't have the authority to tell a company how the label should look," Kweder said. "We have to negotiate with the company the specific language."
She said Merck had rejected a number of FDA proposals and FDA rejected some of Merck's ideas.
"A strong ability to require changing the label would be very helpful," she said.
Kweder also said the FDA's powers are limited when it comes to post-approval studies that might show problems.
Pharmaceutical companies are required to report adverse events, but Kweder said, "We don't have the authority to tell them, 'You must do this particular trial.'"
She said although FDA officials have "a fair amount of influence" and "for the most part are reasonably successful" in getting drugmakers to perform additional clinical trials, they do not have legal authority to require such testing, which Kennedy noted might be an important authority to have.
FIXING MEDICAID TOP STATE PRIORITY
The nation's governors and the Bush administration agree the Medicaid program, which provides healthcare for 53 million Americans, needs reform and part of that is giving states more flexibility to design programs.
Some disagreement remains, however, as the National Governors Association wraps up its meeting this week in Washington, on the administration's goal of reducing Medicaid spending by eliminating loopholes in federal law that allow states to transfer money among various agencies to maximize their federal match rate. Some states argue they are not violating the law but simply using it to their best advantage -- indicating this issue will be on the table for some time to come.
States are facing difficult decisions on Medicaid -- which now accounts for 20 percent to 30 percent of some state budgets. The entitlement is crowding out education in terms of priorities, and although the federal government requires certain segments of the population to be covered by Medicaid programs, governors are worried they will have to make substantial cuts in services to the optional populations they want to cover. These often are the working poor -- who normally would not qualify for Medicaid but cannot afford private or even employer-based health insurance. As more companies raise co-payments and deductibles or even drop insurance for employees, more people end up on Medicaid.
Gov. Mark Warner, D-Va., chairman of the NGA, told Health and Human Services Secretary Michael Leavitt Tuesday, "You have seen from us a real willingness to be at the table for as long as it takes," referring to negotiations on Medicaid reform. He warned, however, that fixing problems with Medicaid will not solve the ills of the entire healthcare system.
"We must find ways to lower the overall costs of healthcare in this country," Warner said.
Leavitt remarked that in talking with the governors for the past several days, he has found some common themes, including one that "block grants are not the answer" to the Medicaid program.
The Bush administration for the past several years has considered changing Medicaid funding from a state-federal matching formula without a limit on federal spending to a fixed federal payment in a block grant format.
The NGA has a list of recommendations for changing Medicaid, which include giving states more flexibility to determine eligibility for optional populations and eliminating some of the red tape involved in getting permission to make changes to program changes.
One recommendation is to allow states to partner with cities and counties to develop local healthcare networks and another is to allow states to institute co-payments for beneficiaries based on income.
Other ideas include creating benefit packages that look more like commercial-insurance plans and allowing states to work with employer-sponsored health insurance -- possibly supplementing the cost of such coverage.
RECOMMENDATIONS FOR MANDATORY REPORTING
Four states have laws requiring hospitals to report data publicly on hospital-acquired infections and the Centers for Disease Control and Prevention said some 30 more states are considering such legislation. Public health officials, therefore, asked CDC's Healthcare Infection Control and Prevention Advisory Committee, or HICPAC, to develop recommendations on how such mandatory programs should be set up.
Mandatory reporting ultimately could help patients and physicians decide which hospitals provide the best quality care. CDC and HICPAC leaders outlined the committee's recommendations Monday -- which do not include one that says states should adopt such laws.
Dr. Patrick J. Brennan, HICPAC chairman, told reporters during a briefing that the committee did not find enough evidence to conclude mandatory reporting actually makes a difference in reducing hospital-associated infections.
"This document is a guide to best practices, it is the ... opinion of HICPAC," Brennan said. "We have not put forward this document as model legislation."
Some 2 million patients acquire hospital-associated infections each year and 90,000 of them die, costing the healthcare system billions of dollars.
States with laws in place include Illinois, Pennsylvania, Missouri and Florida, and Kathleen Meehan Arias, president-elect of the Association for Professionals in Infection Control and Epidemiology, said the goal is to "reduce healthcare associated infections to a reducible minimum."
HICPAC recommended reporting systems use established public-health surveillance methods, employ people with experience in infection control, track practices that prevent infection, and provide feedback to physicians.
Dr. Denise Cardo, director of CDC's Division of Healthcare Quality Promotion said, "We don't know yet if public reporting will reduce the number of infections, but we do support collecting information that can lead to improvements in patient safety."
Brennan said the recommendations are directly linked to clinical processes, and the committee called for hospitals to track the most common in-house problems -- central venous catheter infections, lab-confirmed blood stream infections and surgical-site infections.
Brennan admitted he did not know what effect mandatory reporting would have, but he said one problem area could be adverse selection of patients.
"We acknowledge the potential adverse consequences of public reporting," he said, adding "(the) selection of less complex or lower risk patients for the purpose of ensuring better outcomes would be reported in the public disclosure process."
HICPAC spent a year studying the issue before making its recommendations, which come on the heels of a study showing about half of hospitals in one survey did not follow routine standards for preventing surgical site infections.
MEDPAC SAYS MEDICARE SHOULD PAY FOR QUALITY
The Medicare Payment Advisory Commission or MedPAC recommended to Congress on Tuesday that the senior health-insurance program pay healthcare providers differently, based on quality of care.
Medicare should pay more for better quality care from hospitals, home-health agencies and physicians, the report said -- the same recommendation MedPAC made last year for Medicare's managed-care plans.
Quality indicators should include the use of information technology in doctors' offices, laboratory data and prescription claims information, the report said.
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