DENTISTRY vs. the FDA

Letter from NADL to further explain actions.
fda_and_government_officials_explore_increased_oversight.pdf

A response by John Wu, Ph.D.  Professor of Operations and Marketing, California State University Monterey Bay and President, AsiaNetworks LLC .
Response to NADL action.

Here is a site for those of you that are unfamiliar with the Chinese dental lab industry.

Be sure to take a look at the photo galleries especially from 2006.  Check out the photos of the exhibition hall.   You will notice the participation of all of the major dental manufacturers.

http://www.dentalsouthchina.com/e-brief.asp

Is the NADL really worried about materials and training of foreign technicians?

I can’t figure out what they were thinking! I think most of us would agree that overall the finest dentistry in the world is probably done right here in the U.S. I have been in this business since 1968 and , for the life of me , I cannot think of any major threat that has been posed on the American public by my lab or any of my colleagues.

In spite of that the NADL has decided that they need to protect the public from myself and my colleagues by launching a weapon of mass destruction/request for regulation on our industry. This is being done at a time when most small and medium sized labs are scrambling to figure out where they are going to position themselves to deal with all of the other issues facing our industry…… rapidly increasing new and expensive technologies etc. In their war against foreign laboratories and the expanding global marketplace they are making moves that will ultimately make it harder for us to compete. Would it not have been better to allow the industry/combatants to do what all war strategists must do to compete…find out their weaknesses then access your own strength and then exploit it! Instead the NADL wants to try ending the conflict by changing the rules of the game.

I sincerely worry where all of this is going to end up!

Oh, and one more thing. Those of you that have been members of the NADL and supported these efforts …. Sorry! You are just a casualty of war. What is it called? Collateral damage………. friendly fire?

This is the place where you can make your opinions known. Just click on the comments button above on the right.

August 2007 - NADL board and NBC Trustee meet in Chicago, and discuss potential actions on this issue.

September 2007 - Working Group on Import Safety submits initial report to the President. Working Group and FDA asks for public comment from industry on recommendations

September 2007 - NADL develops a recommendation letter to the Working Group that was reviewed and signed off on by both the NADL executive officers, NBC executive officers and general counsel

September 2007 - NADL releases a press release in Followup to the letter submitted to the Working Group

October 2007 - Working Group holds an in person meeting in Washington, D.C

November 2007 – Working Group releases a final report to the president that would address recommendations for each federal agency involved

Yes, whenever a regulatory group gets involved it will increase costs. Since many offshore labs meet iso9001 regs or are set up recently to meet pretty tough standards(Dentsply Prident and many others) those will be the ones to benefit. They have a strong since of public relations and will make sure they are not grouped into the materials offender list.We have the ability as a group to develop a PR campaign to announce the stringent guidelines we are willing to set as domestic laboratories to insure our products are delivered without the concerns both the FDA and Nadl have. Can we police ourselves with the help of our manufacturer’s and suppliers. Don’t they have as much at stake. Do we really have something to hide?This, if introduced properly may give the public a better view about who we are and what we do to defend their (consumer) interests. Our opportunites may exist better for us now than they ever have.

COPY of Letter Sent by NADL to FDASeptember 10, 2007Division of Dockets Management (HFA 305)Food and Drug Administration5630 Fishers Lane, Room 1061Rockville, MD 20852

Dear Interagency Working Group on Import Safety,

I am writing on behalf of the National Association of Dental Laboratories to submit recommendations relative to the safety concerns of dental devices that are imported into the U.S. market for consideration by the Working Group.  This document is for submission for the October 1st meeting of the Working Group.  Currently, the dental laboratory industry makes up approximately $5.5 billion of the over $80 billion in annual sales for dentistry overall in the U.S.   As it relates to the specific interest of the Working Group, the dental crown and bridge market (which appears to be highest percentage of types of dental devices being imported),  represents millions of devices being imported into the U.S. annually for use by U.S.dental patients.   Although dentists prescribe the type of device they deem appropriate for a dental patient and write a prescription for such device, the device is actually manufactured by a dental technician employed by a dental laboratory, which could be foreign or domestically headquartered.  The current environment of dentistry lends itself to the attractiveness of using foreign dental laboratories to supply services for the U.S. dental patient population.  The factors that have set this in motion are:     a) A focus on the price of dental devices driven by dentists seeking a lower cost product and reimbursement levels set by dental insurance plans and b) An increasing demand for dental services by U.S. patients, predicted to double by 2015 that corresponds with a declining percentage of dentists to U.S. citizens and a decreasing number of U.S. dental laboratories and dental technicians in the workforce.  By definition, dental laboratories fall under oversight by the FDA relative to QS/GMP regulations. However, the majority of domestic dental laboratory establishments are exempt from registering with the FDA based on current regulations.  Dental laboratories are significantly different from most medical device manufacturers that the agency regulates, both in terms of scope of the manufacturing process (devices are custom designed based on a prescription for an individual patient as prescribed by a licensed dentist) and the size of business in comparison with other regulated entities, in that a typical dental laboratory in the U.S. employs 3.5 people.

Established in 1951 The NADL represents over 1,400 members, comprised mostly of commercial dental laboratories that manufacture their products domestically and serve the needs ofU.S. dentists and patients.  However, we also have members that utilize the services of foreign dental laboratories as outsource vendors for varying percentages of their production needs.  Our association has aggressively educated our membership during the last six years about the already present regulatory requirements administered by the Food andDrug Administration that apply to dental laboratories. We have also worked to educate affiliated organizations that represent our members’ clients, such as the American Dental Association, the Academy of General Dentistry and related prosthodontic organizations.  The key elements of interest are QS/GMP standards and those that relate most closely to import trade, labeling and disclosure a products point of origin.  The dental laboratory industry through the efforts of our association and our affiliate certifying body, the National Board for Certification in Dental Laboratory Technology have provided numerous tools to assist dental laboratories and individual dental technicians in improving their operations and service delivery forU.S. dentists and patients.  The resources already present and utilized by dental laboratory facilities include:

• The Dental Appliance Manufacturers Audit Scheme (DAMAS) QualityAssurance process (a process which follows closely the FDA’s QS/GMPregulations but is tailored to the dental laboratory industry)Web Link: http://www.nadl.org/DAMAS.cfm.   The DAMAS process provides stringent protocols for raw material traceability; vendor qualification; andcorrective action procedures. The program requires a third party audit of the dental laboratory once a year for the first three years, and then every three years thereafter.

• The Certified Dental Laboratory program focuses on OSHA infection controland Bloodborne pathogen standards and product remake procedures  Web Link: http://www.nbccert.org/CDL.shtml  The resources already present and available for the individual dental technician include:  • Competency Standards, a 300 page step by step guide for themanufacture of dental devices by an individual technician. The standards cover the five main disciplines of dental technology: partial dentures, fulldentures, crown and bridge, ceramics and orthodontics.

• Certified Dental Technician program, which is accredited by the American National Standards Institute.  Web Link: http://www.nbccert.org/CDT.shtml.

The programs above are intended to achieve accountability from within our industry. Continue reading »

In a letter to the FDA dated September 10, 2007, Bennet Napier, executive director of the NADL, opened a Pandora’s box that will be the single most destructive thing that has ever happened to the dental laboratory industry in this country. Under the guise of consumer protection, the NADL has requested the regulation of our industry by the FDA. This effort is based on some very naive assumptions and very shortsighted thinking. In regard to consumer protection, it is an action being taken to fix a problem that does not exist. For as long as I have been in this industry there have been efforts to elevate the respect, status, and profits of our industry thru licensure and the certification of laboratories and technicians . Having failed I think that this is nothing more than another attempt. One that may be nothing more than “shooting ourselves in the foot”………Or worse!

The first assumption is the idea that any bureaucracy can do anything efficiently and effectively. Even if you can find one that accomplishes the assigned task it is never done without an excessive budget. This fact alone will lead to labs eventually paying registration fees and fines along with the additional costs for record keeping, inspections, and implementing various GMP and other operational standards.

My second concern is what this type of regulation is going to do to the laboratory/dentist/patient relationship. I can foresee the possible if not probable shift of liability to the laboratory resulting in the additional expense of higher liability insurance premiums. Continue reading »