The NADL has formally asked the FDA to implement more stringent regulations of laboratories and dental restorations. Proponents agree that increased FDA oversight is in the best interest of the industry and will help enhance product quality, while opponents contend that new laws will simply add to our problems, not alleviate them.
It's all over the news.
Not all Chinese imported products are safe. In response to the recent recalls of dog food, toys and toothpaste, President Bush formed the Presidential Interagency Working Group on Import Safety in July. Comprised of the secretaries and agency heads of seven federal agencies including the FDA, Consumer Product Safety Commission, Department of Transportation and Department of Homeland Security, the group is charged with ensuring the safety of imported products.
In September, the NADL sent a letter and had a meeting with representatives from the group, recommending that the FDA implement more stringent regulations of laboratories and restorations. The NADL asserts that laboratories are under-regulated, with few states having legal requirements for technicians to be certified and no mandates for dentists to document or disclose the source of dental work to patients. If adopted, the recommendations would impact both U.S. and foreign laboratories as well as dentists (see NADL's proposed FDA guidelines).
The FDA's interest in our industry is not new; we've been on its radar for several years. The dramatic rise in imported restorations--an estimated five million are being imported annually from other countries--prompted the FDA to take a closer look at both foreign labs and domestic operations.
At this point, the NADL is making recommendations for the FDA to consider. The FDA has been gathering information, and currently has placed regulatory requirements for foreign and domestic dental laboratories on a list of guidance documents that are being considered for development in 2008*. There are more than 80 other possible guidance documents on the list and the FDA acknowledges that it's not possible to complete its entire agenda.
The regulation dispute has long waged in our industry, and given that another controversial topic--offshore outsourcing--is now part of the equation, it's no surprise the NADL's actions have sparked debate.
A recent LMT e-poll shows that nearly 62% of the respondents say they support the NADL's efforts to boost FDA regulation with many pointing out that this is a much-needed, positive change that will result in a better-protected patient. "Our profession is healthcare. What we do and the way that we do it significantly affects people's quality of life and overall health," says Pete Murphy, National Dentex's national coordinator for clinical relations who is based in Seattle. "There should be standardized guidelines that let consumers and dental professionals know what they are receiving."
Other supporters feel the FDA's involvement is inevitable and the NADL's actions will help prevent the agency from imposing its own, more severe regulations. "Regulation is a hard pill to swallow, but the lab industry is on the radar screen and FDA is here to stay...The NADL is taking a proactive line rather than waiting for the FDA to impose unwelcome restrictions on our businesses," says Warren Rogers, president, Knight Dental Studio, Oldsmar, Florida.
One key point among those who oppose stronger regulatory oversight: It's the dentist--not the laboratory--that's responsible for the patient's health. "It's up to the dentist to know who is making his or her dental restorations, the qualifications of each technician who comes in contact with each case, and whether or not each restoration is acceptable!" says one respondent from Colorado. "Dentists must have a personal knowledge of and relationship with the lab and technicians doing the work. I am not against certification, but I am basically against regulations that pass the buck away from those who are really responsible."
The issue that's causing the most debate involves certification. Although the NADL falls short of asking the FDA to require laboratory certification, it does recommend the CDL and DAMAS programs as "best practices," and this has lab owners worried. A common concern is that large laboratories can more easily afford the extra costs associated with certification, and small operations will ultimately be driven out of business. "I agree with some of the NADL's efforts. But, overall, I see the cost of implementing it's recommendations as having a negative impact on the smaller laboratory that may find it financially difficult or unfeasible to comply with the additional recordkeeping and registration fees the FDA might charge," says Kris Van Cleve, owner, Dental Prosthetics Services, Cedar Rapids, Iowa.
On the other hand, those in favor of certification hope that tougher rules will force lower-quality domestic labs to adhere to a higher standard, thus boosting quality overall and leading to better wages. One opponent counters that certification doesn't necessarily equal quality: "I've been a technician for 36 years. I honestly don't want to spend the time or money for certification when I have seen many certified technicians that can't come close to putting out a product as good as mine."
*The FDA's Center for Devices and Radiological Health (CDRH) has established a docket (2007N-0357) to gather comments or draft language on the proposed 2008 guidance documents. It will also use the comments to help it prioritize the order in which the guidance documents should be developed. For details, visit http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html.