In the musical “Oliver!” based on Charles Dickens’ novel, a poor child draws the ire of his caretakers when, after a meager portion of food, he famously holds out his bowl and says, “Please, sir, I want some more.”

Consumer advocates and others would argue today that we don’t necessarily need more food  – but they would hold out their bowl for more food regulation, especially from the FDA.

It’s not as if we need reminders that there are some serious shortcomings when it comes to how some food manufacturers operate (and how the FDA regulates them), but a recall of more than 200 million eggs this week gives us one whether we’d like it or not.

There’s been growing pressure on the agency to tighten its regulation of food, and it is starting to look like proposed federal legislation is going to deliver just that.

Most Capitol Hill watchers are predicting the Food Safety Modernization Act will come to a vote after the Labor Day recess. It’s likely to pass, though there is some debate about a few proposed amendments including one that would ban outright the usage of BPA, the plastic lining found in cans and in other packaging. Some pundits say attaching the BPA ban would kill the whole bill.

The FSMA would give the FDA greater authority regulate food and place a greater legal burden on food manufacturers to be more transparent when it comes to how they control their product from conception to landing on your dining room table. In other words, food manufacturers would have a lot more quality control work on their, well, plate.

A timely summit last week featured representatives from the Pennsylvania Dept of Agriculture and Dept of Health as well as the Grocery Manufacturing Association.  Led by Dr. Rene Massengale, Associate Professor of Biotechnology, who heads Food Safety and Quality Assurance Academic program at Harrisburg University of Science and Technology, Dr Massengale said industry has generally reacted positively to the potential changes coming from Capitol Hill.

While industry is supportive in principle to the idea of increased food regulation, Dr. Massengale said there is some nervousness out there about what kind of regulations finally emerge from any new Congressional law. Another wrinkle: Some manufacturers of relatively lower risk items, say candy versus eggs, are saying to feds “leave us alone, we already do this well,” she says. Her event attracted representatives of companies and organizations participating in the food supply system including agricultural growers and producers, food processors, food distributors/wholesalers/ retailers and members of related trade associations, as well as middle and upper-level managers from small and medium-sized organizations and managers, directors or owners responsible for food safety and product quality, such as HACCP, QA/QC, and process control professionals.

So, is “more” on the way?

It’s beginning to look that way.  Watch this space in the coming months as track the FSMA’s progress on Capitol Hill.

For more information

Request “The New FDA Drive for Food Safety” paper here.

Blog:  http://foodsafetyquality.blogspot.com/

You can follow Dr. Massengale’s frequent updates on Twitter here:  http://twitter.com/RDMassengale

Device Industry Begins Preparation for Excise Tax as Some Call for Repeal
Although the excise tax on medical devices that was part of the health reform bill does not take effect until 2013, members of the device industry have already begun preparing for its imposition, and have indicated that they will continue to call for the repeal or revision of the tax. Some reports are indicating that one of the primary issues associated with the tax will be the determination by the Treasury Department regarding which products and transactions will ultimately be subject to the tax. Industry groups, including the Medical Device Manufacturers Association, have indicated that they will be focusing their efforts in the near future on persuading members of Congress to repeal the tax.

FDA May Further Modify Advisory Panel Voting Processes
FDA officials have indicated that the agency is considering making additional changes to the voting processes of its advisory panels following the announcement earlier this year that panels would no longer use “up-or-down” votes for approval of products. The agency has indicated that it is considering allowing for greater discussion on panel members’ reasoning behind their voting decisions.

Regulatory Notices – FDA Seeks Comments

The FDA has announced that it is seeking comments on the use of rapid response surveys to obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions when the agency must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health. Comments are due by October 5, 2010. More information is available here.

The FDA has also announced that it has submitted a proposed collection of information regarding premarket notification for medical devices to OMB for review and clearance. Comments on the collection of information are due September 10, 2010. More information is available here.

FDA to Co-Host Meeting on Pediatric Cardiovascular Device Development
The FDA has announced that it will co-host a public workshop, in conjunction with the National Institutes of Health (NIH), and with support from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI), entitled “Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices.” The topic to be discussed is pediatric cardiovascular device development. The workshop will be held on September 30, 2010, from 8 a.m. to 5:30 p.m. in San Francisco, California. More information is available here.

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

Weighing patient safety against encouraging medical innovation is no easy task. The FDA has been struggling with it off and on, mostly on, since its creation in 1906 (yes, I had to look it up). It took very gross meat and a crusading Upton Sinclair to force the FDA’s very existence. Hopefully we won’t need anything so dire to effect some positive change this time around.

Over the past decade most critics have said the agency has been too understaffed to effectively regulate the F(ood)and D(rugs) of its name. When it comes to assessing its medical device activity, it’s a bit tougher to analyze. But that just might get a little bit easier. Last week the FDA unveiled two big evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

The Center for Devices and Radiological Health (CDRH) assessment consists of two preliminary reports. The first focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The second evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

The two documents overlap in several places and cross-reference information. Both are available here.

“Having FDA 510(k) clearance is a big milestone, one which further validates” a company’s products, notes WellDoc CEO Ryan Sysko. He’s just been through the 510(k) approval process with a happy outcome (approval in July).

“We found the FDA to be very open and willing to talk, willing to offer guidance,” Sysko says. His advice to other young companies is “first thing, call the FDA, talk about your product and what it is trying to accomplish, and get a sense of the regulatory climate.”

Make sure the FDA understands your technology or product so they can better understand how doctors and patients use it, stresses Sysko. Also it important to put quality system programs in place early on and have strong employee training programs, Sysko adds. “It is absolutely critical to show the FDA your good work, too” he emphasizes. FDA on audits wants to see SOPs, document control, training records, among other items, and you’d better be ready to demonstrate it.

Back to what the FDA did last week.

CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan. The committees collected and reviewed input from public meetings, open dockets, data analyses, and input from CDRH staff over the course of several months to prepare the complementary evaluations.

We’ve heard from some medical device firms that scream bloody murder (off the record, of course) about how cumbersome and counter-intuitive the FDA’s 510k system has been. Even the agency admits that “concerns have been raised both inside and outside of the FDA about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while fostering innovation. Concerns about the program have centered on whether it allows devices to enter the market without sufficient safety and effectiveness evidence and whether a lack of predictability, consistency, and transparency is hindering device development.”

In other words, the FDA seems to understand that the system is broken. Is this a fix? Most say it is a good start, if nothing else. “The challenge the FDA will face is how do we take what’s being accomplished with technology while ensuring patient safety,” Sysko says, noting it’s obviously easier for Apple or Google to launch a new innovation than it is for medical device companies.

FDA makes some effort to defend itself, specifically CDRH, in its announcement. “CDRH uses science to guide its regulation of medical devices across the total product lifecycle,” notes the agency release. “At any stage of that lifecycle, new, unfamiliar or unexpected scientific information may arise that warrants a change in the FDA’s thinking, expectations, and actions.” CDRH says it is trying to find the right balance between the ability to adapt its approach as new science emerges and to provide predictable regulatory pathways.

“Taken together, these preliminary reports show a smarter FDA – an agency that recognizes both sides of our mission to protect and promote public health,” said CDRH Director Jeffrey Shuren, M.D. “The agency is ready to make necessary improvements to support device innovation while assuring patients receive safe and effective devices.

“Even with our significant outreach, it’s important to remember that these recommendations are preliminary,” said Shuren. “CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments.”

While the agency has a prime directive to protect patient safety, it doesn’t want to slow or even destroy a medical device that’s ready to roll and ready to help patients. But the agency has often been accused of slowing innovation to the detriment of patient safety. It’s a balancing act, to be sure, and we should at the minimum give the FDA for addressing this and trying to come up with a good solution.

Selected recommendations and the key public health objectives they address include:

Fostering Device Innovation

• The 510(k) report recommends major improvements to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k) but which do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process – called the de novo classification process. The recommendations include streamlining the process and clarification of CDRH’s expectations for submissions that undergo this type of review.

• The science report recommends that CDRH make better use of scientific experts outside of the agency by developing a web-based network of external experts using social media technology. This network would help CDRH staff leverage outside knowledge without serving in an advisory capacity.

Enhancing Regulatory Predictability

• The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance document would help clarify what information submitters should include in their 510(k) submissions so that they can plan accordingly. In addition, this would also help the center’s review staff obtain the type and level of evidence necessary to make well-supported decisions without as much need for time-consuming follow-up requests for information.

• The science report recommends use of a standardized “Notice to Industry” letter that would generally be issued as a “Level 1 – Immediately in Effect” guidance document to quickly communicate when CDRH has changed its premarket regulatory expectations due to scientific information that has emerged about a certain device type. CDRH currently communicates this kind of information through individual interactions during the review process, which can lead to delays. These letters would provide greater clarity to affected manufacturers, in a timelier manner, about CDRH’s expectations with respect to a particular group of devices.

Improving Patient Safety

• The 510(k) report recommends that CDRH consider revising regulations to explicitly require 510(k) submitters to provide a summary of all scientific information known or that the submitter should reasonably know regarding the safety and effectiveness of the device under review. This is not required now for 510(k) submissions and, as a result, relevant information may not be included in an initial submission. This summary would help CDRH review staff to more efficiently make decisions, and potentially avoid extensive follow-up inquiries and questions.

• The 510(k) report recommends that CDRH develop a guidance document that clarifies when a device should not be used as a predicate, such as when the device has been removed from the market because of safety concerns. The report also recommends that the center consider issuing a regulation that would clarify the circumstances under which the center would exercise its authority to rescind a 510(k) clearance to remove an unsafe device from the market and preclude its use as a predicate and also consider whether additional authority is needed.

• Both reports recommend that CDRH build upon public databases to include meaningful, up-to-date information that supports good decision making and promotes the safe use of devices. This could be accomplished by improving the current 510(k) database so that it includes summaries of FDA review decisions, current labeling and photos. In addition, the science report recommends that CDRH build upon the existing transparency website to provide more immediate information on how devices are regulated.

For more information:
CDRH Preliminary Internal Evaluations

CDRH Device Approvals and Clearances: 510(k) Clearances

Complying with the NERC CIP requirements is expected to be a major expense for power producers and the like in the coming years. To date, companies have spent tens of millions of dollars to formally document and test the support for internal control assertions required by CIP and maintaining this documentation will continue to be costly beyond the first round of documentation.

Let’s take a look at some of the most important components of a good NERC CIP compliance program:

Automate The Testing & Reporting Of All Of The Technical Controls

An important concern for power producers is finding a cost-effective method of documenting, storing, and analyzing CIP control assessment work. Management is also looking to meet all the technical requirements spelled out in the requirements. In the first year, many companies have elected to use spreadsheets to tackle CIP documentation because they are familiar with the tool. Moreover, some companies prefer to use spreadsheets because the CIP requirements are still evolving.

Spreadsheets have significant limitations that will increase compliance risks. In addition, depending on spreadsheets for CIP documentation may prevent companies from improving their compliance process and risk management capabilities. In the first year of CIP compliance efforts, many internal auditors and project consultants have advised power producers to use their existing spreadsheet software to document compliance efforts. There is no way that these tools are sufficient to document all relevant accounts, account assertions, risks, controls, and deficiencies. The only way to truly document everything is to automate the process.

Use File Integrity Checks To Assure Your Systems Are In A Desired State

It is very difficult to compromise a system without altering a system file, so file integrity checkers are important. A file integrity checker computes a checksum for every guarded file and stores it. At a later time you can compute a checksum again and test the current value against the stored value to determine if the file has been modified. Some lesser quality file integrity checkers use a 32 bit CRC (Cyclic Redundancy Check). Attackers have demonstrated the ability to modify a file in ways that the CRC checksum could not detect, so stronger checksums known as cryptographic hashes are recommended.

One of the challenges in using a file integrity checker is the false positive problem. When you update files or apply system patches this changes the file. Creating the initial database of signatures is easy; keeping it up to date is much harder. However, even if you only run the checker once (when you first install the system) this can still be very valuable. If you are ever concerned that the system was compromised you can run the checker again to determine which files have or have not been modified.

The other challenge with a file integrity checker is that you have to have a pristine system when you create the first reference database, otherwise you may be creating cryptographic hashes of a compromised system while feeling warm and fuzzy that you are implementing good security. It is also very important that you store the reference database offline or an attacker may be able to compromise the system and hide their tracks by modifying the reference database.

Test System Configurations Against External & Internal Policies

Testing is an investigation conducted to provide stakeholders with information about the quality of the product or service under test. Testing also provides an objective, independent view of the configurations to allow the facility to understand the risks in the implementation of the configurations. Test techniques include, but are not limited to, the process of executing a configuration with the intent of finding “bugs”.

Testing can also be stated as the process of validating and verifying that the configurations:

• meets the business and technical requirements that guided its design and development;
• works as expected; and
• can be implemented with the same characteristics.

Testing, depending on the testing method employed, can be implemented at any time in the development process. However, most of the test effort occurs after the requirements have been defined and the coding process has been completed. As such, the methodology of the test is governed by the configuration methodology adopted.

Testing can never completely identify all the defects within your configurations. Instead, it furnishes a criticism or comparison that compares the state and behavior of the configurations against principles or mechanisms by which someone might recognize a problem. These principals or mechanisms may include (but are not limited to) specifications, contracts, comparable products, past versions of the same product, inferences about intended or expected purpose, user or customer expectations, relevant standards, applicable laws, or other criteria.

A study conducted by NIST in 2002 reports that bugs cost the U.S. economy $59.5 billion annually. More than a third of this cost could be avoided if better testing was performed.

A primary purpose for testing is to detect configuration failures so that defects may be discovered and corrected. This is a non-trivial pursuit. Testing cannot establish that configurations functions properly under all conditions but can only establish that they do not function properly under specific conditions. The scope of testing often includes examination of configurations as well as execution of those configurations in various environments and conditions: does it do what it is supposed to do and do what it needs to do.

There are so many areas that can be addressed for automating that it would take dozens of pages for them all to be discussed. This blog was intended to give you a start on what you need to do if you truly want to ensure total CIP compliance.

James Holler is founder of Abidance Consulting.

Amid continuing debate about the timing and shape of the Senate’s food safety bill (the House passed a version in July 2009), comes a new issue that affects companies in the food, drug, device and cosmetic industries.

Several months ago, FDA Deputy Chief Counsel for Litigation Eric Blumberg told industry representatives at the FDLI Annual Conference that the agency is prepared to dust off the three-decade-old “Park Doctrine” to augment FDA’s continuing efforts to ratchet up its enforcement profile. The doctrine stems from the United States Supreme Court’s decision in United States v. Park, 421 U.S. 658 (1975). In principle, it allows the government to pursue misdemeanor charges against a corporate officer for alleged violations of the Federal Food, Drug, and Cosmetic Act, regardless of whether the officer is aware of the existence of a violation, as long as the officer holds a position of responsibility so that that individual could have initiated preventive or corrective action and, for whatever reason, failed to do so.

Park represents a strict liability standard, so no warning letter is required. FDA need only request that the Department of Justice file charges based on FDA’s conclusion that an officer is guilty of misconduct, which is effectively defined as failing to know what FDA believes one should have known. In sum, what an executive does not know can be more than harmful.

The scale of punishment for misdemeanors ranges from one year in prison and/or a maximum fine of $100,000 for each count, ranging to much higher where injury or death are involved. Courts can impose mandatory prison sentences, and if FDA believes a substantial risk of injury or death is involved, judges can increase the length of prison sentences.

At a time when corporate resources are stretched, the entire spectrum of regulatory compliance issues has become every bit as critical for senior management and counsel as the other bet-the-company issues that confront each company on a day-to-day basis.

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