The FDA continues to signal that food enforcement is back in fashion.

Last week at a press-only briefing the agency tried to demonstrate its proactive side, saying it was “taking steps to protect the public following the early identification of Salmonella Tennessee in one company’s supply of hydrolyzed vegetable protein (HVP) and again last week the agency issued an open letter to the food industry calling for more transparent product labels.

So what’s it all mean?

We spoke recently with Kim Egan, partner in the law firm DLA Piper’s Product Liability practice, and a regular source for us on these and other FDA-related matters.

“The food industry is facing a “perfect storm” — high-profile food-borne illnesses continue to plague the global supply chain, prompting President Obama to create the Food Safety Working Group, and the First Lady has declared war on childhood obesity, including a focus on food industry marketing to children, “junk” food in public schools, and the nutritional content of school lunches,” Kim points out.

I happened to see the harrowing film “A Perfect Storm” at my sister’s house last week and if I am an official in the food industry, an expert like Kim using “Perfect Storm” and “Food Industry” in the same sentence would get my attention.

Kim notes that President Obama said in a March 2009 weekly radio address that “At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.  That’s what Sasha eats for lunch.”

The Executive Memorandum announcing the First Lady’s Let’s Move campaign said that “[n]early one third of children in America are overweight or obese — a rate that has tripled in adolescents and more than doubled in younger children since 1980.  “Taken together, the new Administration’s focus on food has in turn pushed FDA to renew efforts to improve food safety and more aggressively enforce existing food labeling regulations,” Kim adds.

It’s all part of a more active FDA across the board, Kim notes.

“FDA has stepped up enforcement of existing regulations.  In August 2009, FDA reorganized its food oversight function and moved the Office of Foods into the Office of the Commissioner, giving food safety and food manufacturing enforcement greater visibility.  FDA appears to be focusing particularly on health claims made by food manufacturers, such as its recent warning letter to General Mills that it had no scientific evidence to support cholesterol claims on Cheerios cereal,” Kim adds.

As Kim explains, FDA said that the General Mills claims that Cheerios reduced cholesterol meant that General Mills was advertising Cheerios as a drug, an unapproved one at that.  FDA has also been focusing on health claims made by dietary supplements, the most notable examples of late being dietary supplement products that purported to be effective against the HINI virus.  There is an effort underway to improve front-of-label nutrition information for all food packages, and Senator McCain introduced legislation in February 2010 to strengthen FDA authority to regulate dietary supplements.

Congress has had food safety legislation in the works for a couple of years now.  Highlights of that bill include:

• The Food Safety Modernization Act that is now making its way through Congress will require foreign suppliers to use “risk-based reasonably appropriate preventative controls” to prevent adulteration and reduce hazards.
• FDA would be required to implement new food safety regulations within a year of enactment.  FDA would also have two years from enactment to “expand the technical, scientific and regulatory capacity of foreign governments,” which could include multilateral agreements and international harmonization of the Codex Alimentarius.  FDA would also be required to expend resources on foreign inspections.
• Having said that, however, the majority of food-borne illness outbreaks since 2006 have been caused by domestic products or other products from North America , including fresh spinach, peanuts, jalapeno peppers, and tomatoes.

“In short, we can expect further pressure on food manufacturers to improve quality control,” Kim says.  “We can also expect continued pressure on food manufacturers to adhere strictly to promotional and nutritional labeling requirements, and we can expect those requirements to change in some possibly meaningful respects in the coming years.”

For more information, request “The New FDA Drive for Food Safety” paper here:

FDA May Ask for Rescission Authority for 510(k) Clearances

CDRH Director Jeffrey Shuren has stated that, as the agency considers proposed changes to the 510(k) process, it may request additional authority from lawmakers, including 510(k) rescission authority. The agency has said that it is challenged by a lack of robust ability to rescind device clearances. Industry officials argue that any new powers should be limited and restrained, while patient advocates praise rescission authority as an important step towards strengthening the safety of devices cleared through the 510(k) process.

Devicemakers Worried About Bayh’s Retirement

Devicemakers with facilities in Indiana, including Boston Scientific, DePuy Orthopaedics, Medtronic and Zimmer, have expressed concern about losing support in the Senate following Sen. Evan Bayh’s retirement at the end of this year. In announcing his decision to step down, Bayh touted his advocacy for device companies as a major accomplishment; the industry employs more than 45,000 in the state.

FDA Appoints Two to Tobacco Panel

Reports are stating that the FDA has selected Jack Henningfield, VP for research and health policy at Pinney Associates, which works on behalf of GlaxoSmithKline, and Neal L. Benowitz, a UC San Francisco professor who has consulted for GlaxoSmithKline and Pfizer, to a panel responsible for regulating the tobacco industry.

China Health Reform Spending Benefits Device Manufacturers

The $125 billion in spending by the Chinese government to start a national health insurance system is benefiting manufacturers of medical devices, including makers of imaging and diagnostic equipment. $41 billion of this amount is being spent to build 31,000 hospitals and equip them with diagnostic and imaging equipment.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

The past several months have brought forth numerous bits of news, pronouncements, expressions of concern and general uncertainty about the device regulatory regime, but also about FDA’s regulatory paradigm in general.  The recent piece in the New York Times regarding disagreement about the diabetes drug Avandia and the controversy involving accusations of conflict of interest by CDER head Janet Woodcock in the consideration of competing applications for enoxaperin, in the wake of last year’s resignation of Dan Schultz at CDER has led many to wonder where FDA is going under Dr. Margaret Hamburg.

Clearly, the new leadership at FDA is now acutely aware of the number and scale of the issues confronting FDA.  In their overwhelming majority, the scientists and technical specialists at FDA are dedicated and committed individuals.  At the higher levels, however, FDA has suffered from a series of problems, none more troubling in its long-term implications for the future of the industries it regulates, than its absence of imagination.

The FDA’s approach to science is rooted in statistical models, and those models and the people who analyze their results are wholly unwilling (as a matter of culture) to do finely tuned, meaningful risk-benefit analysis.  Several years ago, FDA’s own internal assessment cautioned that this blind reliance on statistical analysis will render it entirely incapable of assessing a new generation of complex devices, medications and combinations. The FDA is earning a reputation for inability to approve a product either safely or accurately, because it evaluates products in a statistical vacuum, without regard to societal benefit, need or even real-world safety variables.

There is some hope to be found in the fact that CDRH recently admitted that it needed new methods and new thinking, precisely along these lines.  That represents a refreshing start, but it will only make a difference if it is inculcated in FDA’s culture as a whole. Dr. Hamburg has quite a challenge ahead of her.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

FDA Seeks Comments on Proposed Information Collections

The FDA has announced an opportunity for public comment on several proposed collections of information. The agency is seeking comment on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking. The agency is also seeking comments on a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency also seeks comments on its Guidance for Industry on How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine. Comments are due by April 19, 2010.

In addition, the agency is seeking comments on Antimicrobial Animal Drug Distribution Reports and on its Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Humanitarian Device Exemption Regulation: Questions and Answers. Comments are due by March 22, 2010.

FDA Seeks Comments on Proposed Data Falsification Rule

The FDA is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. Comments on the proposed rule are due by May 20, 2010. More information is available here.

Court of Appeals Agrees to Delay E-Cigarette Decision

A federal court of appeals has agreed to stay the decision of the U.S. District Court for the District of Columbia that lifted FDA restrictions on e-cigarettes. The court ruled last month that the FDA misused its authority when it classified e-cigarettes as a drug-device combination and placed the products under an import alert.

Drug Companies May Have to Wait Longer for REMS Final Guidance

It is being reported that the final guidance on risk evaluation and mitigation strategies (REMS) may be delayed, as the CDER staff developing the recommendations must also review all proposed REMS from drugmakers.

Companies Comment on Proposed Combination Products Rule

Manufacturers of combination products, including Johnson & Johnson, have submitted comments on the FDA’s proposed rule on good manufacturing practices (GMPs) for combination products, saying that the rule needs more guidance and should better address legacy products.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

In Washington, D.C., experts tracking the political shifting sands often advise you to watch what someone does, not what they say. Applying that to the FDA suggests the agency is starting to take risk management enforcement a bit more seriously.

Here’s a good example. Earlier this week (Feb. 16) the agency approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs) manufactured by Amgen Inc. The company’s risk management program or Risk Evaluation and Mitigation Strategy (REMS), requires health care professionals to provide their patients receiving an ESA with a Medication Guide that contains information for patients on how to safely use a drug.

And earlier this month, the agency requested a 23% hike in its budget to help it more aggressively pursue food, drug and device safety (plus its new tobacco initiative).

More action and more dollars could add up to a more active FDA in 2010.

Make sure to read our previous post: Risk Management Matures Beyond the Spreadsheet

Welcome to the 894,302nd and counting piece about Toyota’s fall from manufacturing grace.

We don’t need to devote a lot of space here to recounting Toyota’s problems. You probably know the story: After months of hemming and hawing, the once-proud carmaker finally acknowledged the obvious this month and said it was recalling a boatload of cars that have accelerator pedal problems.

But it gets worse: Yesterday (February 9, 2010) Toyota added that it was also recalling over 400,000 Prius, Lexus because of a brake problem as well as additional problems with the Camry and possibly the Corolla, too. For now, the jury is still out on exactly what went wrong (beyond how badly Toyota handled the PR side of this).

Yet we’re writing about this today because, even as Toyota’s massive problems are being probed, analyzed and dissected by experts from various industries, the issue of supplier quality management (SQM) doesn’t seem to be coming up much.

That’s too bad, because one of the few good things that could come out of all of this is reminding car manufacturers, medical device makers, pharmaceutical companies, food manufacturers and a host of other businesses that supplier quality management is key to being a profitable, effective company that only gets good headlines (See box below, Sal’s Tips).

“Gone are the days when manufacturers can say suppliers can’t have an impact on their success” or, perhaps in the case of Toyota, a spectacular failure, says Dun & Bradstreet analyst Jim Lawton. He also has a background working on medical device issues with Hewlett Packard.

Lawton’s first lesson gleaned from Toyota is that companies should strongly consider focusing on their core competencies and outsourcing other stuff. For example, companies should work hard with partners to understand risk and develop procedures and programs to mitigate it.

“Unfortunately, the medical device industry is not out in front when it comes to managing supplier quality,” worries Jim. “They are all about taking out costs,” he adds. For more of his excellent insights, check out his recent interview with Industry Week.

That can be a case of being penny wise and pound foolish, agrees Sal Lucido at AssurX. ‘Supplier quality management has not gotten the attention it should, because it’s complicated; involving the processes and politics of other companies. It’s hard enough to manage your own company’s issues let alone those of your global suppliers,” Sal says, adding that he believes lessons can be learned from Toyota’s missteps.

Sal’s Tips: Lessons Learned From The Toyota Fiasco

Toyota’s pain could be others gain, IF they learn from what happened to a once-lauded manufacturer. Sal lists some lessons:

• The costs associated with the loss of your company’s reputation are incalculable.
• Product quality includes both the actual and the PERCEIVED view customers hold of your product.
• Ensure you have visibility to the data you need to detect problems early. Prevention is an order of magnitude less costly than late reaction.
• Don’t rely solely on return on investment calculations to direct your process improvement efforts. Sal states as an example that, “ROI calculations are effective when it comes to making decisions such as purchasing automation equipment, but they can fall short when it comes to upstream process improvement investments such as SQM.”

SQM often also gets short shrift because it is harder to calculate in terms of the return on investment (ROI), Sal notes. “When supplier issues are addressed with band aids and tape, they can be hidden from view – for a while. But the day of reckoning always comes.” This is one of the lessons we all may be able to learn from Toyota’s predicament. “The further back in the supply chain, the less attention it gets,” says Sal.

But the Toyota case might make it easier for others to calculate their return on investment in supplier quality. “Decades of reputation building (not to mention billions of dollars) by Toyota has been washed away in a matter of days! It’s very sobering if you are a manufacturer,” Sal points out.

Some good can come out of Toyota’s very public problem if we use it as a wake up call to look at our own house and make sure the processes are sound throughout, starting with supplier quality.

CDRH Publishes Strategic Priorities for 2010

CDRH has published its 2010 Strategic Priorities. The four major identified priorities of CDRH include: fully implementing a total product life cycle approach, enhancing communication and transparency, strengthening the workforce and workplace, and facilitating innovation and addressing unmet public health needs. Within these priorities, CDRH has set forth a timeline, in which it states that it intends to begin implementation of the recommendations of the 510(k) Working Group by September 30, 2010. Director Jeffrey Shuren has indicated that he plans to review public comments from a meeting this month and the findings of an internal review, to be completed this summer, before making any proposals. In its notice announcing this month’s meeting on the 510(k) process, the FDA stated that it is seeking comments pertaining to four areas: predicate devices; new technologies and scientific evidence; practices for managing the high volume of 510(k) submissions; and post-market surveillance.

CDRH has also announced that it intends to launch a “Unique Device Identification” (UDI) system by Sept. 30, 2013.

FDA Moves Radiological Devices Branch to OIVD

FDA Commissioner Margaret Hamburg has signed orders to officially move the Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety, a result of long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA. OIVD will now house four product divisions – the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and radiological devices.

FDA Enforcement Letters on Marketing Campaigns Doubled in 2009

An FDA official has stated that the agency sent 41 enforcement letters in 2009 related to questionable drug-marketing campaigns, almost twice as many as it issued in 2008.

Mark Mansour is a partner in the firm, Bryan Cave, LLP