TISSUE ENGINEERING
from petri dish to patient
FEDERAL REGULATION &
LEGAL ISSUES
RESEARCH FUNDING
The federal government sponsors many agencies that research and develop products like engineered tissues. The problem here is that is the general population willing to pay increased taxes for research into this biotechnology that they might not even need in their lives?
The FDA's program to run the administrative facility to overlook the approval process for combination products tissue engineering costs about a $1 million per year. Even as a new field with many risks and a huge potential, money is huge factor in making this technology available to all which some are not willing to pay.
However, these taxes pay off for the others of society who can benefit from tissue engineered products. As FDA overlooks the development of the field, the products and prices will become regulated too, which overall makes these products less expensive and more readily available than they are now.
OWNERSHIP AND PATENTABILITY OF TISSUES
In the United States, companies and organizations can file patents on cells and other biomaterials. However, a question arises when people donate their cells: who actually owns the donor cells, the company or the donor?
Current regulations do not mention anything about transferring ownership of cells or other biomaterials. However, if an individual wants to transfer certain materials to another person, for usage rights, both can sign a materials transfer's agreement (MTA).
FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) regulates all regenerative products and has yet to establish complete guidelines for usages of tissue engineered products. This is a result of the FDA's product classification guidlines which limits commodoties to three categories: drug, biologics, or devices.
Tissue engineered products fall under all three of the general categories. This hinders the progress of product development as it will have to undergo review from multiple centers for approval.
Ever since the 1990s, the FDA has been interested in TE. Even though the process for a medical device to be on the market is convoluted, the FDA has been proactively developing standards for TE products to be marketed, which ultimately follow phases of clinical trials which other medical products follow,which is described in the diagram at the right.
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