FDA Blog Unabashed

The CNC FDA Blog provides discussion and comment on current topics and events related to the import of goods from foreign industries. This blog is not intended to provide regulatory or legal advice, but is intended to provide insight garnered from 32 years of federal government service, including 28 years at the U.S. Food and Drug Administration. 

March 11, 2009: What's the Plan?

The Blakely, Georgia peanut caper has kept food safety, Salmonella, and FDA in public discourse as to what should be done. One theme that keeps re-appearing is the notion the solution for food safety is a "Plan" - industry is to be required by regulation to have a "Plan". 

I keep thinking of the trees that will be lost with the creation of plans that pass through mutliple bureaucratic paper shuffles. Is it really "Plans" or "Principles" that need to be promoted through regulation?

What kind of a "Plan" is required by a medical device company subject to the Quality System Regulations (QSRs)? Well, I am confident you will not see the word "plan" except for a reference to statistically valid sampling plans. But there are some interesting requirements in the device good manufacturing practice regulations:

• A Quality System
• A Quality Audit to ensure the system is effective
• Purchasing controls that include the evaluation of suppliers ability to provide products that meet specifications
• Procedures to identify all stages of the product from receipt through production to distribution (lot codes, etc)
• Production and process controls including process validation ( answers the question of how do you know the process is doing what it is supposed to do)
• Procedures for implementing corrective and preventive action
• Documentation and written procedures
• Lots of other relevant stuff

So what's the "Plan" for foods? Hopefully, the use of some of the best and most practical principles found in the historical drug and device arena - the notion you can not test quality into the product, that you must build quality into the product. Foods are not an innocous, low tech industry that just need a "Plan". The core principles of drug and medical good manufacturing practices are very relevant, or, at least, should be.

December 17, 2008: Post-Administration, Post-market and a new Commissioner

The transition to a new administration and new year is really being filled with a pick me syndrome for a new Commissioner. There seems to be a pretty large consensus to the notion FDA needs a major overhaul, but what does that mean? It seems most of the press talks about FDA being too close to industry for drug and medical device pre-market approvals and little of anything else.

But what happened to the post-market issues? The import issues? Lack of adequate oversight of foreign sources of FDA regulated products? Few foreign inspections? Lack of IT capacities to do the public health job effectively and efficiently for both domestic and import operations? The melamine indicator of product safety vulnerabilities? Weak monitoring systems for adverse events related to drugs, devices, foods? Weak and inconsistent presence at the borders? Good manufacturing practices? Verification? Weak presence in trade negotiations? Weak regulatory requirements for many foods? Recalls? Consumer complaints? Outdated job descriptions and component mission statements? Current widget counting v.s. outcome based objectives? Ineffective budget and contract management systems? Weak management and leadership?

Whoever is the next Commissioner, he or she will not be able to afford to be a 1 or 2 issue leader and let the rest ride on the broken machinery. The new Commissioner must be actively engaged in the rebuilding of Agency infrastructure that is also needed for effective and efficient post-market activities. Knowledge of scientific principles applied in a regulatory context and integrity are no brainers, but so should the knowledge and application of best management practices.

November 21, 2008: China Grand Opening, Transparency or not 

At last, it is done. A tangible FDA presence of 7 in mainland China 24/7. So, what are the expectations? High on transparency, low on deliverables. It would be nice to turn back the clock to the mid-ninties when trade launched with boosters without considering all the product quality and safety factors, but, obviously, that is not possible. So, meaningful deliverables will be very slow in coming.

Just like Wall Street, FDA really does not know what is going on in China in part because of the lack of transparency, both on the parts of the Chinese government and FDA. The Wall Street problem seems to be due in part to greed "+" ambiguous paper instruments of unknown value. For some imported FDA regulated goods,  it is another "+", ambiguous or unknown product safety.

So, who are the Chinese manufacturers who consistently make provide safe products based on best practices designed to ensure the safety? And which U.S. manufacturers do the same? Based on what? And which ones do not? Those questions should be readily answered with voracity,and represent some core values for transparency in supply chains needed to minimize public health risk and provide confidence in trade.

My hope is the magnificent seven can make rapid strides in developing a verifiable process for ensuring product safety on both sides of the border that makes sense. But the FDA team still needs the trade expertise. Even if the small staff ensures a specific chinese facility complies with FDA standards at a certain time, how will they ensure those are the products being delivered to the U.S. in invoice and bill of lading information throughout the year? The U.S. border staff basically just has the invoice information (what, how much, and price) to make an admissibility decision.

The foreign manufacturer/processor may be at the headwaters, but the delivery chain winds a long way to the U.S. mouth. Gee, maybe the border operations and foreign operations should be under the same roof? Maybe real FDA reorganization and leadership has to change? Let's hope or else it will just be an expensive paper tiger.

November 13, 2008: Stoned again

The melamine story continues. FDA issues Import Alert #99-30 to theoretically stop all products from mainland China that might contain milk or milk derivatives as ingredients that might contain melamine. There might be a possibility the same or other products from other countries might have been made from the same or different ingredients that might have melamine. So products might come to the U.S. from other countries that might have melamine contamination, maybe.

So with all its might, FDA has implemented an adminstrative tool, the Import Alert, that might better ensure imported commodities declared with certain FDA product codes and China as country of origin might not contain melamine. The price to pay will be product sitting for weeks waiting for sample results, and FDA's small staff to agree the analytical reports are real and correct and that the shipment should be allowed entry. Is that really a wise choice? Is that just the easy way out for FDA?

 Why not have a global melamine Import Alert to really be sure? That could be the right thing to do, wouldn't it? Anything that might have melamine should be subject to the alert, shouldn't it? Is FDA suggesting that FDA registered firms are intentionally contaminating product with melamine? Why let them be registered? I know we can register ourselves with FDA, but why the melamine folks? Don't they have to be registered to import into the United States? FDA doesn't know who the melamine folks are? uh-oh.

Again, FDA has decided everything is at risk because they do not have, and have not routinely sought and considered the knowledge of the quality and safety of products in specific supply chains from foreign sources before they are shipped. They ask for the information in import alerts to be applied to shipments after being offered for entry, but why not before? FDA is responding as if it has no choice but to post an overreaching import alert to try to relieve itself of any other responsibility. There are choices, but the wrong one is made when an institution stays within the confines of the virtual moat. 

Ocober 25, 2008: Stoned

It is a travesty, the reported public harm in China caused by melamine in the food system - from kidney stones to death. Is it just coincidence National Institutes of Health released a report this month stating there has been a 30% increase in chronic kidney disease in the United States over the past decade? I really hope so. Here's the link to the report: http://www.nih.gov/news/health/oct2008/niddk-08.htm

It is very interesting that the NIH report covers the very same years of the booming international trade and overwhelming increase of FDA regulated products, the vast majority of which we either injest or get injected into or put directly on our bodies. 

Susan Thixton authored an article on pet health in Natural News.com ( http://www.naturalnews.com:80/024583.html ) on October 23, 2008, citing the NIH study. She further stated FDA examination of less than 1 % of food imports is inadequate to ensure the food is free from melamine contamination, especially considering the reported wide-spread contamination and recall in countries of human food products from China.

My previous blog entry cited reports of the contamination of ammonium bicarbonate (a baking soda). Ammonium bicarbonate is also used in industries besides food, pharmaceuticals being one. The melamine story is becoming the poster child of everything that is wrong in the current government safety nets for imported product safety. It is a time of great opportunity for industry to demonstrate the effectiveness of best practices that ensure all products meet specifications designed for safety.

The food industry should take lessons learned from the more regulated medical device and drug industries and consider instituting some type of impurity profile system, lot by lot, for trending and detecting and identifying aberrations in ingredients and finished product.

There should be an on-going indepth analysis of trade trends, recalls, adverse health reports and other relevant information commensurate with the study of disease trends in the U.S. Maybe there is no connection of melamine and trade patterns with the NIH findings. But who knows what such objective scientific endeavor might disclose? Perhaps more direct ways to keep our kidneys from being stoned in the United States.

October 22, 2008: Forward and Backwards

Today Taiwan television reports  the possibility that ammonium bicarbonate, a common food ingredient, from mainland China is contaminated with high levels of melamine. If this is confirmed there will likely be another wave of concern for baked goods on the U.S. market.

Melamine is becoming the poster child for everything that is wrong with product safety in international commerce. The current FDA paradigm for ensuring the safety of imported goods can not be allowed to continue.  According to information on FDA's web site, there are approximately 350,000 registered foreign food firms involved with shipping millions of entries of food related items. FDA inspects less than 100 of the firms per year.

So why should there be concern? FDA's system at the border for determining admissibilty has about the same information you get when you go grocery shopping. You know what it is, what it cost, where you purchased it, and maybe where the product was produced. It's not good enough for determining all significant risks or hazards.

There has been a lot of call for "traceability" requirements to better enable recalls and food borne outbreak investigations, especially for imported goods. Unless the traceability is linked to safety requirements and related record keeping, there will be little value but a lot of costs. There are no record keeping requirements under the FDA general food good manufacturing practice regulations (GMPRs).

Traceability should be easy to implement. If you know the complete supply chain from the manufacturer leading to importation, then you have the traceability backwards. Is that really too complicated? To be implemented and effective, the FDA Information Technology system has to be smart and capable of monitoring products in complete supply chains. And, FDA must start evaluating supply chains before shipment, not just the last transaction offering importation into the U.S.  Start with the low risk supply chains from the manufacturer forward, and give credit for compliance with FDA requirements at the border with expedited entry.

June 20, 2008:Today's topic - BLT's

I love this time of year and I love my summer time BLT's. There is something special about the notion of watching a small, green, round tomato budding from a withering yellow blossom and maturing into an irregular, round, juicy, red tomato ripe for slicing and topping off BLT's.  But I am no longer a gardener. What am I to do?

FDA is recommending consumers avoid raw, large, red, round or Roma type tomatoes, unless one knows the tomatoes are not linked to the Salmonella saintPaul outbreak. Small, red tomatoes (cherry/grape) and those with vines still attached and those grown at home are ok based on some undisclosed information.

FDA action in the current outbreak is largely based on findings reported by CDC (Center for Disease Control). CDC findings are largely based on interviews of victims of the diease and other individuals surrounding the incident. I am wondering what the CDC questionaire must look like. It must include questions not only related to what foods people purchased and ate, but also what color and shape of food the victims ate or handled.  Maybe the questioning goes like this:

Q#1: Have you eaten anything yellow?

A: No

Q#2: Have you eaten anything red?

A: Yes

Q#3: Have you eaten anything square?

A: Only one brownie and my wife ate the rest and she didn't get sick. She has a weight problem though.

Q#4: Have you eaten anything round?

A: Yes 

Q#5: Have you eaten anything red and round?

A: Yes: apples, watermellon balls, cranberries, cherry and grape tomatoes in leafy lettuce salads, sliced round tomatoes on salads, hamburgers, subs and BLT's.

Uh-Oh.

May 29, 2008:

Have you noticed the FDA is much better at saying they can not do particular activities to protect public health and safety because of resource constraints than they are at describing what they are actually doing? FDA keeps talking about what they will theoretically do in the future during the seemingly endless string of Congressional hearings while quickly admitting, with little detail, the current state of affairs is inadequate to ensure protection from significant potential risks posed by imported goods.

It is a mistake to ignore and not analyze how FDA is currently organized; how it makes administrative or management decisions; how it allocates resources; how it assigns, plans and reports work; how it tracks and evaluates performance; how it does or does not work with industry and trade; and, how it plans a budget.  The current state of affairs, the culture, has significantly contributed to the Agency's inability to establish and implement effective import programs.

Effective solutions will only come from the accurate statement of the problems and related causes. The claim of insufficient funds alone as the cause of all the Agency's shortcomings is inadequate. How are existing resources used? What are the management practices? There are, after all, around 10,000 FDA employees, not just the 200 part time inspectors to evaluate and inspect 16-18,000,000 entries from 200+ countries through 300 Customs ports. This is not new news.

To say more money for the Agency is automatically value added to the Agency performance can be a very slippery slope. Not all effective solutions can be legislated or funded. Just maybe there is a very serious management problem at FDA that only new leadership, management and organizational structure can fix or significantly improve. Meaningful accountability requirements need to be attached to any new FDA resources to help ensure the appropriate use of the funds. How are human resource allocations going to be made? By a risk-based approach? How? By whom? How will the public know if a funded project works? Who will be responsible?

Solutions can be developed and implemented, but not with a big check attached to only a 30,000 foot description of a purpose.

May 6, 2008:

Great ideas need to be executed in order to deliver benefits. It appears the Senate (HELP Committee) is developing some comprehensive fixes to FDA's operations to better ensure product safety regardless of origin, here or abroad. Absent, it appears, is recognition of the contingencies necessary to execute the great ideas.

Integrated Information Technology (IT) is essential for a real, risk-based FDA regulatoy system. FDA does not have integrated IT. There can never be enough humans hired to compensate for IT systems that can not deliver in near real-time,  all the information needed to make regulatory decisions based on science, product experience, environment, and conditions of manufacture, transport and storage. There must be real investment and vision for the long term development of integrated IT for FDA and HHS.

FDA's current organizational structure is not designed to develop and maintain an organization with the skills and tools to oversee FDA regulated products in international markets and supply chains. The notion of a foreign inspectorate is good for all FDA regulated products, not just drug products. The Inspectorate should reside in a new, directly funded organization designed to manage and execute foreign inspections, border operations and inspections of importers and consignees - an organization designed to manage and integrate information from the entire supply chain or import life cycle for all FDA regulated products to enable risk-based decisions.

April 25, 2008:

Old news is new news. FDA and the international regulated industries remain in the news thanks to the same unresolved issues. The underlying regulatory, industry practice and oversight issues related to the recent contaminated heparin story is the real story -  little effective FDA oversight of imported goods. The vulnerabilities presented by imported substandard and dangerous products is not new, just worse because of the volume of international business, FDA's inability to adjust quickly enough to changing business and international trade, and industry's hope little government intervention is needed.

All stakeholders have a significant role to play to clearly identify the problems, and,  then develop and implement practical solutions. This is not a one time shot. Today's solutions can turn into tomorrow's problems. Legislation needs to be developed that will not only encourage compliance by both domestic and foreign firms to the same industry practices to ensure safety of the products, but will also provide a regulatory framework that is flexible for industry to apply innovative and emerging technologies to rapidly emerging and changing risks and market demands. FDA must start to use an account system, monitor the supply chains, and leverage information with other federal and state agencies, foreign governments, industry and trade groups.

The time is ripe for objective action and investment in the future. It is time to get the green lanes of safe products flowing at the border. The time is ripe to develop and implement an FDA system that can distinguish between the safe and risky, and that provides trade incentives for safe goods shipped to the U.S.