Responding to BTS scandal, Sen. Schumer introduces bill expanding FDA oversight of tissue industry.

Responding to the stolen body parts scandal and 122-count indictment of Biomedical Tissue Sciences (BTS) by a New York District Attorney, Senator Charles Schumer (D-NY) introduced legislation on April 7 designed to "improve the oversight and regulation of tissue banks and the tissue donation process, and for other purposes."

There is no question the US tissue banking industry will be under increasingly stringent scrutiny by the US Food and Drug Administration (FDA) if the Safe Tissue Act (S. 2609) is passed.

The centerpiece of Schumer's bill are requirements mandating that the FDA inspect each regulated tissue establishment "not less than once every two years." In addition, the agency would be required to conduct "periodic audits of all documentation submitted by each [tissue] establishment . . .to determine compliance under applicable requirements, including; (1) that human cells, tissues, or cellular or tissue-based products are obtained by the establishment legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice."

Paying for the increased inspections and audio may be borne by the tissue establishments themselves if the Secretary of Health and Human Services (HHS) decides to do so. The bill gives the Secretary the authority to set user fees to be paid by individual tissue establishments.

Earlier "discussion" drafts of the legislation did not make the FDA the centerpiece for overseeing much more strict oversight of the tissue banking industry, said Patricia Aiken-O'Neill, Esq, president and CEO of the Eye Bank Association of America (EBAA). In a note to her membership, O'Neill, who worked very closely with Schumer's office in drafting the bill, wrote: "the original draft amended the 1984 National Organ Transplant Act (NOTA) and deputized organ procurement organizations (OPOs) as the sole organizations to receive any potential referrals from funeral homes, morgues or crematoriums."

O'Neill told Transplant News the EBAA plans to continue working with the bill's sponsors, as well as the committees of jurisdiction. "The bill is vastly improved from earlier discussion drafts, but concerns remain, particularly with 'user fees', which aren't appropriate, necessary or warranted."

Other provisions in the bill include the development of a model consent form, enforcement including the ability to impose civil and criminal penalties, accreditation of tissue establishments and their personnel, and a determination of "reasonable payment" as an amendment to NOTA.

The bill requires the HHS secretary to publish in the Federal Register a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor, or the legally authorized representative of a potential donor, of human cells, tissues, or cellular or tissue-based products. In addition, the consent form must contain a section on how the tissues, cells and products would be used e.g., "transplantation for medical purposes, transplantation for cosmetic purposes, therapy, research, or medical education."

Tissue establishments would also be required to provide a description of the recovery process if asked by the donor family or a family representative, inform the donor or representative of that right to receive such a description, and if the establishment is accredited by HHS.

Failure to comply with the requirements of the model consent form can result in a civil penalty of not more than $5,000.

However, if an establishment, or an individual employed by that establishment knowingly uses fraudulent information, or fraudulent means of obtaining consent, the civil penalties are much harsher. A first violation could result in up to a $10,000 fine, imprisonment for up to six months, or both. A second offense could result in a civil penalty of up to $250,000, up to 10 years imprisonment, or both.

The bill also mandates the HHS secretary to promulgate regulations to accredit tissue establishments, and personnel who "participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products."

Finally, the bill mandates that the HHS secretary promulgate regulations defining "reasonable payments" in NOTA as it "relates to human tissue and tissue-based products."

The Safe Tissue Act (S. 2609) has one co-sponsor - Senator Patrick Leahy, (D-VT). It has been referred to the Senate Committee on Health, Education, Labor, and Pensions.