Collins committee presses FDA to complete tissue bank rules

WASHINGTON – In 2001, a 23-year-old Minnesota man died four days after a doctor transplanted what turned out to be infected bone tissue into his knee during what should have been a routine operation.

The Centers for Disease Control and Prevention later found that the tissue donor’s body was allowed to remain unrefrigerated for at least 19 hours before the tissue was harvested. The donor had committed suicide, which cast additional doubt on his time of death.

During the next six months, as Brian Lykins’ parents sought out the reasons for their son’s sudden death, they realized that private companies that store and transport skin, bone and cartilage tissue did not have to follow specific federal safety and health rules. The authority to monitor and regulate the tissue industry falls under the U.S. Food and Drug Administration.

“It became very clear at that point that the CDC had no power to bring about change in this industry, and the FDA was not going to do its job,” Brian’s father, Steve Lykins, told the Senate Governmental Affairs Committee on Wednesday. “One and a half years after Brian’s death, the FDA is still only proposing regulations for the tissue industry. Nothing has changed.”

The committee chairwoman, Sen. Susan Collins, R-Maine, chastised the FDA during the hearing for failing to make final safety regulations that govern the tissue bank industry.

Collins complained that the FDA has done little in the two years since her Senate panel uncovered serious safety concerns with how some private companies handle and store human tissue used in transplants. Collins said she plans to introduce legislation this week that would force the FDA to issue final regulations within 90 days.

“It is obvious to me that without a statutory deadline, the FDA will continue to delay and delay,” Collins said.

Collins introduced similar legislation last year, but it was stripped from a larger bill because the FDA promised it would act on its own within the year. She complained that no “discernible progress” has been made toward issuing the regulations.

But Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research, responded that the agency is not delaying the issuing of new rules, but it faces a number of obstacles before completing them. He did not specify those obstacles or how long it would take to complete the task, but said the rules are complex because of the rapidly growing number of medical uses for human tissue.

“We are actively engaged and moving forward,” he said.

Areta Kupchyk, who worked on the tissue issue as an FDA attorney before leaving for private practice in January, said in an interview that the regulations were nearly complete when she left. But she said a lack of personnel and other resources have slowed development of the regulations. Those obstacles might also pose a problem when it comes to enforcing the new regulations.

“The FDA doesn’t have the money and they’ve got to start thinking of creative ways to make this happen, such as third-party inspection programs,” she said.

Kupchyk said current FDA regulations simply ask companies to follow “good practices” currently written and enforced by the industry itself to prevent infectious diseases. The new FDA regulations would detail tracking, storage and shipping regulations, and would give the agency more power to punish companies that don’t comply.

Kupchyk had been the lead counsel during an investigation of the Georgia processor that handled the cadaver tissue for Lykins’ knee. CryoLife Inc., among the nation’s largest tissue processors, was forced by the FDA to suspend its tissue operations after an investigation found that tissue had been released despite concerns about harmful bacteria. CryoLife has since resumed its tissue processing business.

The tissue industry has grown considerably since 1993, when the FDA wrote its first set of rules to address concerns that improperly handled tissue could transmit HIV, hepatitis B and hepatitis C.

More than 800,000 tissue products were available for transplant last year, up from an estimated 475,000 five years ago, according to the American Association of Tissue Banks. The industry’s growth is in large part due to technological advances and the increasing knowledge of researchers and doctors on how to use skin and bone tissue to treat patients.