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:

As weird weather slaps both U.S. Coasts [flooding in Southern California, hail storms in the South], the forecast at the FDA looks like medical device firms could be in for some heavy stuff of their own in 2010. This isn’t Chicken Little saying the sky is falling here. Let’s review a few FDA actions in the past several weeks and probe a bit for their possible significance to medical device firms.

For starters, a relatively casual-sounding entry on the FDA’s transparency blog could signal the beginning of much more robust scrutiny and inspections for medical device companies.

Here’s a little of what it says,  “FDA seeks input on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly. Disclosure of full inspectional observation reports would still require the same review for non-public information as it does now.”

Depending on how this in interpreted and ultimately implemented, it could mean that medical device companies are going to see a lot more inspectors doing a lot more inspections.

So far, most comments favor the FDA doing this, though one anonymous commenter raises a good point from the medical device manufacturer side:  “Since FDA-483s are evidence gathered for potential legal action, it may be a violation of a company’s legal rights to have a FDA-483 released without a legal review and opportunity for a response. Also, some FDA-483s contain annotations about findings corrected during an inspection, etc. What would be the purpose in releasing such information?

Occasionally, there have been errors in findings by FDA investigators that have to be corrected after the original FDA-483 is issued. What would be the opportunity to publicize the mistakes made by FDA in correcting these errors?

The due process accorded in the current process was placed there for a purpose. Has anyone explored why the current process is in place?

Certainly, the improvements to ‘protect the public health’ are admirable, but what is the real purpose of this move?”

That’s a fair question. We encourage your comments. I think it could spell trouble for medical device firms.

“This is big and could mean more inspections [and legal exposure] for medical device companies,” agrees my blogging colleague and Bryan Cave law firm Partner Mark Mansour.

He also cites the appointment of Joshua M. Sharfstein to be the principal deputy commissioner of the FDA after serving as acting commissioner for Food and Drugs from March 29 to May 25, 2009.

“Sharfstein is incredibly enforcement minded,” says Mansour. [Look for a more in-depth legal analysis of this from Mark’s blog later this week]. “He’s giving the push” for more enforcement of medical device companies.

At the same time, CDRH has issued its Fiscal Year 2010 Strategic Priorities report – and it hints an awful lot about hiking enforcement activity to better protect the public’s health.

But wait, there’s more.

The FDA recently scheduled a public meeting on Feb. 18 to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

Last September, the agency announced it had asked the Institute of Medicine (IOM) to conduct a comprehensive study of the process. The IOM study is not expected to conclude until March 2011.

In the meantime, the FDA has convened its own internal working group to evaluate and improve the quality and consistency of the agency’s decision-making in the 510(k) process as well as its administration of the program. The February meeting will support the efforts of the agency’s internal working group.

The Feb. 18 meeting will run from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Md. If you want to attend or otherwise participate you have to register by 5 p.m. on Feb. 12, 2010. The agency is accepting written or electronic comments by March 5, 2010.

The meeting will be Webcast live here.

We’re not even through the first month of 2010 yet, and it already feels like a lot has happened – and there’s almost certainly more to come.

You’ve got to admit, the FDA certainly seems earnest about its intention to make its operations more transparent. Earlier today (January 12) the agency unveiled the first phase of its “Transparency Initiative,” designed to explain agency operations, how it makes decisions, and the drug approval process.

It’s a timely initiative as the agency has come under fire from some camps for being too lax on the approval process, and too harsh by some others. Another sign that this inititve has struck a nerve: it received more than 900 comments, according to the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein. By contrast, the important eMDR initiative drew about 25 comments at last count.

At today’s briefing, Sharfstein outlined a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. “The launch of FDA Basics is our first step towards making FDA a more transparent agency,” he said. It includes:

• Questions and answers about the agency and the products it regulates
• Short videos that explain various agency activities
• Conversations with agency personnel about the work of their office

Going forward, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each session will be announced on the FDA Web site.

In recent months, the Task Force solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings. The Transparency Task Force received hundreds of comments from various stakeholders, including regulated industry, consumers, patients, health care providers, and others. As a result of comments from the public, the Task Force decided to develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases.

In phase two of the initiative, the Task Force intends to make recommendations to the Commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency’s goal of protecting confidential information, as appropriate. The agency hopes to release those at the end of February.

In the final phase of the initiative, the Task Force intends to make recommendations to the Commissioner regarding FDA’s transparency to regulated industries. They hope to do than in May or June 2010.

We’ve certainly heard some complaints about this initiative, but on balance I think this has to be viewed as an improvement over how the FDA did business in the recent past.

Key will be keeping those comments coming and then waiting to see if the FDA listen to them.

Well, we told you 2010 was going to be a big year for the FDA.

While most of us were enjoying holiday treats or making new year’s resolutions, a leading FDA official said the agency was developing new guidelines designed to establish stricter standards for the data received from tests with human subjects used by medical device makers when they seek approval for a new or altered device.

Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, told The New York Times recently that the FDA most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, Shuren told The Times.

That sound you hear is the new drumbeat saying that the FDA hasn’t been tough enough on medical devices in the past, at least according to JAMA and an article published in the American Journal of Therapeutics which suggest the agency has to get stricter to better protect the public.

AdvaMed, the big medical device trade group, is taking a “wait and see” approach, at least publicly.

Or as Janet Trunzo, AdvaMed’s executive vice president, technology and regulatory affairs, told us recently, “FDA has not released any formal proposals or guidance regarding changes to the premarket approval (PMA) process.  When the agency does so, we look forward to reviewing and commenting on them.  In general, we support efforts to better clarify FDA submission requirements and to ensure patients have timely access to life-saving and life-enhancing medical technology.

Trunzo went on: “It is important to note that the FDA’s approval process for Class III devices is the agency’s most stringent.  On average, the agency spends roughly 1,200 hours reviewing each application, and has the authority to demand additional data and to refer the application to an expert panel for review.  To obtain FDA approval through the PMA process, a manufacturer must submit a detailed application that contains full reports of all investigations of the safety and effectiveness of the device; a full statement of the components, ingredients, properties, and principles of operation of the device; a full description of the methods used in the manufacture and processing of the device; information about performance standards of the device; samples of the device; specimens of the proposed labeling for the device; and any other relevant information.

“Clinical trial data is but one piece of the overall approval process for medical devices, as the FDA requires data to determine biocompatibility, mechanical strength testing, among others, which are not available through clinical trials.  American patients have access to life-saving, life-enhancing technology because the FDA carefully balances the risks and benefits of each new device or advancement in a given technology.”

But Dan Walsh, a senior member of PA Consulting Group’s Life Sciences & Healthcare practice, says there will definitely be tougher standards, and some level of more stringent human clinical trial results.  However, he believes there is room for straightforward 510(k) cleared products that make no substantial claims beyond equivalence to currently marketed products.  Dan specializes in technology strategy and acquisition, medical device product development and improving the effectiveness of commercial launch of new medical technologies.

According to Walsh, another repercussion is that the 510(k) will be more narrowly applied, and there likely will be an extended use of ‘510(k) with clinicals’ submissions because these trials have not required the same statistical power or clinical depth (high in placebo or alternative therapy arms, etc.)

“If all products were required to obtain PMA approval with robust clinical trials, it would likely impede innovation and use of new technologies,” Walsh told us.

“Since the FDA has mandates for both protection of the public health and the oversight of launch of new therapies for unmet or underserved needs, an all or nothing approach is not feasible or practical,” he adds. “If all submissions required clinicals, one could add at least six months and many millions of dollars to the development time and cost for a medical device, all other things being equal.”

Kim Egan a partner with DLA Piper in Washington, D.C. and an expert in this arena who sits on the advisory board of Life Sciences Law & Industry Report, a publication for lawyers, business executives, directors of research and regulatory specialists practicing in health care-related life sciences fields, gave us some interesting observations, too:

• This development is not overly surprising given the open letter to President Obama that FDA scientists sent last year alleging corruption in the medical device approval process.  The division head stepped down year as well.  FDA is under strong Congressional pressure to reform.
• This report is based on a review of cardiovascular devices only — we can expect similar reviews of additional therapeutic areas over the coming months.
• Industry will want to take an active role in the comment period that will follow FDA’s issuance of draft guidance on new requirements.
• The impact on industry may be limited to products that require full PMA approval.  Devices that rely on 510(k) approval need not submit clinical data, so providing the predicate device is unaffected by FDA’s review, the bulk of new devices on the market should not be affected by the new guidelines.
• The NY Times article contains an error regarding personal injury lawsuits.  The reason personal injury lawsuits are limited is not because of the Riegel decision — that decision simply upheld existing law that provides federal preemption to medical device manufacturers, particularly on failure to warn claims.  Because Congress has expressly preempted failure to warn claims for medical device manufacturers, such claims cannot proceed on state law theories.  This is unlike the pharmaceutical area, where there is no Congressional preemption of state law.

It’s a fine line between regulations with teeth that protect the public without slowing valuable new medical devices. Just ask John Hanley, an attorney at Steptoe & Johnson in LA. He represents two medical device companies that have been significantly impacted by the highly conservative approach now being taken by the FDA.

“They have both decided to pursue clinical approval outside of the U.S. before continuing to attempt to navigate the very difficult road to approval here in the U.S.,” Hanley said of the two companies who wished to remain anonymous.

“In fact, it is disappointing to note that even where these companies have had multiple years of clinical data from activities outside the U.S., the FDA has not approved their pursuing expedited routes through the FDA approval process,” Hanley adds.  “Unfortunately, the FDA’s recently adopted strict stances have resulted in the American public being denied the benefit of new medical technologies.  Moreover, it is expected that the FDA’s conservatism will eventually lead to less investment in medical device companies domestically and thus, less medical device innovation in the U.S.”

Yes, 2010 is already shaping up to be an interesting year at the FDA.

Don’t touch that dial, we’ll keep you posted as this story moves ahead.

Risk management is one of those terms that is often used a bit too loosely, warns AssurX’s Sal Lucido. “People say ‘risk management’ but it can mean very different things to people working at different parts of a company.”

For example, the finance and accounting department focuses on documenting and managing risks associated with business financial transactions and reporting as governed by Sarbanes-Oxley (SOX). The information technology group (IT) focuses on cyber security risks, which involves processes such as identity and access management, threat and vulnerability management, and configuration control. The regulatory compliance group is concerned with meeting government regulations, laws and standards applicable to their industry. For example medical device companies must meet regulations imposed by the FDA regarding such activities as quality and incident management. Energy companies must abide by national and state mandated regulations established by NERC, FERC and their respective regions. Noncompliance can lead to fines that sometimes total in the millions.

Across these industries “the Federal Government is actively auditing and levying large fines for those companies found to be out of compliance. The bar is being set higher each year and the penalties are becoming more severe.”

“Having a risk management system that is managed on paper and spreadsheets is just not going to cut it anymore.”

Sal has helped dozens of regulated companies in industries ranging from utilities to medical device manufacturers to better manage their corporate risk data and processes. And he’s observed that they have a lot in common when it comes to handling risk management. Based on his years of experience with many different firms working to address risk, he has some valuable observations and advice.

Across the board, “what we’ve been finding is that information associated with risk management is rarely made available to the departments that need access to it. For example, if the audit department had access to the identified risks and their risk levels, they could use this information to plan their audit activities aiming audits at those that pose the greatest liability to the company. ”

Companies are now looking for tools that “allow for secure collaboration” so that the risk information and data is readily available for all those who need to access it.

”Because each of these departments already have their own processes” companies are looking for applications that allow each group to maintain their own forms and workflows. “It’s critical to have an application that provides processes unique to each group while harmonizing the underlying data” so that each group can access what it needs, when it needs it.

The other trend we are seeing is that companies are looking to move beyond just documenting risks and listing mitigation efforts. They are looking for enterprise applications that can manage the associated business processes. For example, risk assessment and mitigation efforts are tasks that need to be assigned to individuals or teams, with due dates and status updates. In order to ensure projects stay on track there is a need for escalation functionality that automatically emails the appropriate personnel when tasks become due and go late. These activities also have associated workflows and approval routings that need to be managed via software. Of course this type functionality goes well beyond the capabilities of simple risk tracking software and spreadsheets.

The other need we are seeing is related to reports and dashboards. Department and process managers are looking for reports that show risk levels, heat maps, late reports and so forth. The executive staff is looking for enterprise dashboards that report on the state of compliance throughout the organization using easy to read traffic light and gauge or thermometer formats.

Finally the solution should also be flexible enough to integrate with data and systems that are already being used within the company. For example, if a system is already being used to document the status of key risk indicators (KRI’s) such as violations or incidents, “that data should be reported within (and accessible from) the risk management system.”

In conclusion, managing risk across the corporation means something different to each department yet it requires the entire organization to work together. It involves documenting and sharing risk data across the enterprise, managing workflows and tasks, while handling escalation and reporting. Yes, risk management has matured beyond the spreadsheet.

Sal Lucido is VP of Enterprise Solutions at AssurX, Inc.

Well, the eMDR comment period has come and gone – and I’ve got to say I’m a little surprised at the relatively low number of comments. But let’s look on the bright side: What we didn’t get in quantity we might have gotten in quality. This is generally as well-articulated and intelligent a group of comments I’ve read in years.

The overall tone of the letters can be summed up like this: Some want more time to implement the rule, while most generally support the eMDR initiative and call for some changes, mostly of a relatively minor, if probably justified, nature.

A few days before the comment period ended, I spoke with Axis Technology President Mike Logan about why there were so few comments. A handful came in after we spoke on Nov. 11, but he and I are still both a bit surprised there weren’t ultimately more comments.

His view:  “Right now I believe people are taking a ‘wait and see’ approach until more firm details are unveiled. As nice of an idea the eMDR is, there are a lot of risks involved and questions that need to be answered, such as how this impacts standards compliance and potential liabilities.” Axis is a provider of IT consulting and data security offerings for healthcare industry organizations.

Some of the comments seek the kind of clarification Logan believes some in industry need before they are fully confident in using eMDR.

From a medical device standpoint, AdvaMed’s comment is one of the most important since it speaks for so many others (its member companies produce nearly 90 percent of the health care technology purchased each year in the U.S.). It’s also worth noting that the trade association can “get away” with saying things to the FDA that an individual company might not want to risk.

At the outset, AdvaMed says it supports the initiative. But, and there’s always a but in cases like this, they want to see the time stamp issue clarified, a concern echoed by Abbott. AdvaMed also wants the agency to adopt the date and time in the first acknowledgement sent to the submitter by the FDA that the report was received. It also wants the agency to develop a grace period for companies when they have a system outage, among a few other requests.

AdvaMed also wants the final rule to take effect at least two years after publication of the final rule.

On balance, most of the changes requested by the comment letters strike me as reasonable. Industry won’t get everything it asks for here, but I suspect the FDA will work pretty hard to accommodate the most reasonable requests.

Remember, the agency is still smarting from how it mishandled 21 CFR Part 11 in 1997. Back then, it made the rule way too literal and hands-on. Its stated goal to was to advance the use of technology; instead the FDA set it back for several years.

In many ways, I think the agency is to be commended for learning from its mistakes with Part 11 and applying them to its rollout of eMDR. The eMDR guidance is not perfect for everyone, but it’s pretty good for almost all, and that kind of effective compromise strikes me as democracy at its best. Here’s hoping the FDA takes some of the best comments to heart and improves a guidance that’s pretty close to the mark.

To learn more about a COTS solution for eMDR, click here.

After years of budgetary neglect, malaise and a brain drain you could almost hear each time you passed the FDA’s exit on the Maryland side of the Washington, D.C. beltway, the FDA is hiring big time.

They are looking for medical officers, pharmacists, consumer safety officers, biologists, chemists, microbiologists, pharmacologists, statisticians and operations research analysts, among others.

And it’s not a moment too soon. It’s a challenge to get current FDAers to speak on the record about this issue. But off the record we’ve heard from mid-level folks and those higher up the org chart tell us time and time again that the agency is way understaffed — and it felt like the Bush Administration had it in a chokehold for nearly eight years.

“We need these people and we need them yesterday,” a senior FDA official told me this week.

The hiring push also suggests that the FDA in 2010 is going to be a lot more aggressive and proactive agency than the one we’ve been watching for most of this decade.

Need more proof?  FDA’s Regional Food and Drug Director in San Francisco told a RAPS meeting in August that the agency planned to increase its foreign inspections by 100% over the next three years.

A Nobel Peace Prize notwithstanding, President Obama may be disappointing some of his supporters thus far in his presidency. But he’s keeping his promise to revitalize the FDA.

And the hiring push goes beyond the FDA, as an interesting front page article in the Oct. 13 Washington Post points out in the headline is a clue, “A Vigorous Push From Federal Regulators. Consumer, Workplace Agencies More Active.”

“The new regulators display a passion for rules and a belief that government must protect the public from dangers lurking at home and on the job – one more way the new White House is reworking the relationship between government and business,” says The Post article.

But even as we speculate that the FDA will conduct a lot more inspections next year, it’s important to remember something that’s not so likely to change, according to Roh. The most common drug GMP 483 items have been and probably will remain: Responsibilities and procedures of the Quality Control unit are not in writing, written procedures are not followed, control procedures not established, inadequate specifications, written procedures, and failure analysis.

Well, it’s nice to know that some things never change.