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FDA is reviewing more than 300 positions in 20 cities to see whether they could be outsourced to private companies, the Associated Press reports. The original position list included lab technicians and field office workers at facilities where devices are inspected for safety. But it was then revised to include only administrative positions. The National Treasury Employees Union is asking Congress to oppose the plan. And it may succeed; it was lobbying by the NTEU that nixed the agency’s plan to close seven of its 13 field laboratories.

If administrative jobs can be done cheaper and better by the private sector, then the outsourcing plan should be considered. But outsourcing technical people is probably not an avenue that should be traveled.

– From MD&DI’s blog.

It currently takes FDA far too long to review and approve products, according to several medical device companies. Nearly 60% of device companies that participated in a recent life sciences survey said the area where FDA could most improve is faster product turnaround time.The survey, conducted by PricewaterhouseCoopers LLC (PWC; San Jose), serves as a report card on the working relationship between the life sciences industries and FDA. Responses were received from 66 companies, 21 of which were medical device manufacturers. The survey’s authors hope that the report sparks more dialogue between industry and FDA on what changes need to be made on both sides. Providing industry with better guidance was cited as another area for improvement.

According to Tracy Lefteroff, a life sciences industry leader for PWC, the slow rate at which FDA reviews and approves products was the most glaring problem revealed in the report. “Both sides believe there’s still a long way to go between industry and FDA to develop a more efficient and effective working relationship to cut down the review and approval times of medical devices,” says Lefteroff.

He explains that the delays could be partially due to the agency’s staff shortages and turnover ratios. Six in 10 of the life sciences companies said that changes in FDA personnel have caused a break in continuity in at least one of their product reviews. More than half of the device companies also felt that changing a reviewer mid-review could “greatly influence” how products move through the development stage, as the change absorbs more time and resources.

On the other hand, FDA’s most improved area, from a device company perspective, is the feedback the agency provides at the beginning of product development. But this is often not carried through the total product life cycle.

When it comes to enhancing their relationship with the agency, the participating device companies have worked to build internal regulatory expertise, improve standard operating procedures, and implement better quality systems. They’ve also engaged in frequent communication with FDA during product development and have demonstrated knowledge of risk management programs.

The authors were surprised to learn, however, that only 38% of the device companies incorporate FDA feedback into the product development process. Ignoring FDA recommendations could increase the likelihood of delays later in the approval process, a point at which mistakes become more costly from the standpoint of time and resources,” the survey noted. Although this figure does not necessarily indicate what the entire device industry is doing, it points out where improvements may be needed.

The survey’s statistics could give FDA and the device industry more insight into how to work together more effectively. “FDA has been receptive to getting feedback. This is an external survey that gives them validation rather than an internal one, which a lot of times doesn’t tend to tell the whole story,” says Lefteroff. He adds that FDA has found the data valuable and might try to incorporate some of its points in future planning.

“The reality is that FDA is holding most of the cards where most of the improvement needs to take place,” says Lefteroff.

To conduct the survey, PWC also enlisted the help of BIOCOM.
– Maria Fontanazza

A Q&A with Steven Grossman, executive director of FDA Alliance. 

Q: How did FDA Alliance come to be? Who makes up the alliance?

A: I was approached about 18 months ago by a patient group and a research advocacy group and was asked to consider forming what became FDA Alliance. The two groups were concerned that FDA was not getting enough money to carry out its mission and stay ahead of the science—in other words, to get products to the market but to make sure that what gets on the market is safe. The two groups had spent a lot of time strengthening the National Institutes of Health (NIH; Bethesda, MD) and encouraging the pharma and bio industries to invest more in research, only to realize that FDA then needed more capacity to handle the results produced by these efforts.

In April 2006, we established a membership organization. Everyone pays their dues and members are listed publicly. [A membership list can be found at www.strengthenfda.org/members.htm.] The members run the gamut. There are consumer and patient organizations, research advocacy organizations, healthcare practitioners, trade organizations, companies, consulting firms, and individuals. Leading the list are six former FDA commissioners, each of whom had to fight these battles during their time with the agency. They are acutely aware of how difficult it is to get enough resources to do the job well.

Q: Why was there no FDA advocacy group until now?

A: There actually was a group in the early to mid-1990s. It eventually dissolved. It was not identical in structure or positioning, but the goal was the same: to be a voice for FDA resources. But other than that, FDA has not had an advocacy force that could draw attention to its needs.

FDA as a whole does not have a natural constituency. Compare it with NIH. There, all of the different professional societies in the different specialties, plus universities and other organizations, are interested in NIH’s overall budget because of the grants it gives out and the interplay of scientific discovery between different disease areas. So they have organized together and have had a tremendous effect on the growth of NIH’s budget allocations.

It is not the same case with FDA. Food, drugs, biotech, and medical devices are all regulated by FDA, but in different ways. There is no natural reason for these groups to be talking to each other. The nice thing is, when they’ve considered their stake in the larger FDA resource problems, they have given a very good response. Now, advocacy can be done in a more coordinated way. Not only are we a stronger force collectively, but many of FDA’s budget restraints are systemic and not unique to any particular center.

Q: FDA has come under fire in recent years for its performance. That has given fuel to those who want to increase its budget. Did that climate have anything to do with the timing of the emergence of your group?

A: The current climate has been described as being shaky, but previous eras only seem more stable in retrospect. All commissioners experienced difficulties during their tenure and could have been more effective and more efficient with more resources.

What’s really of significance in 2007 is what’s happened to the budget in the last four years. FDA received additional money in the FY 2003 budget for counterterrorism in response to 9/11. The budget has gone up very little in the succeeding four fiscal years. A year ago, as we were just forming, we tried to observe and get a feel for the landscape. What I took away at that point was that no one asked the question, “Are we going to give the agency enough money to do its job well?” This year, a broad cross-sample of members of Congress have asked just this question. This is thanks in part to a lot of people’s hard work in getting the word out that FDA’s resources had fallen well below its mission requirements. The feedback we’ve received is very positive, with lots of concern now being expressed about whether the agency is getting enough money. That’s what we need, instead of the attitude that FDA is just another slug in the budget.

Q: FDA’s appropriation is bundled in with agriculture’s and not the rest of HHS’s. Is this why FDA tends to get forgotten at appropriations time? Can this appropriations structure ever change?

A: That FDA’s budget is part of agriculture appropriations is an artifact that goes back to an earlier time when these things were looked at and organized differently. Is it likely to be changed to put FDA in the Labor and HHS appropriation? Probably not. What is important to us is identifying members of Congress who will be responsive to the agency’s needs, particularly those on the agriculture subcommittee. But even if the jurisdiction were to be changed, the need for advocacy and for relationships with key lawmakers would not change.

Q: What kind of feedback have you gotten from Congress and from FDA and CDRH personnel?

A: Feedback from Congress has been overwhelmingly positive. We found that the FDA resource issue was something that members and staff hadn’t been thinking about. When we brought the issue forward and put it into perspective, people responded to it. We changed the debate. Now the people who are concerned about FDA— members and staff—are the people who can do something about it.

We don’t discuss FDA Alliance with FDA, even though we are advocates on behalf of its appropriation. We are careful as far as that goes—what little contact happens is strictly limited to questions of factual descriptions of programs and budget allotments. It is always about information that is publicly available. I assume the agency is pleased, but I don’t know this to be true. We emphasize that we are doing this because we choose to, not because FDA has asked us to. It has not.

Q: Is CDRH’s current budget enough to accomplish its mission? If not, what is not being done that should be?

A: Our recommendation is that the $230 million that CDRH will get in FY 2007 should be increased by $72 million. That $302 million is only the appropriation part. User fees are extra and above that, bringing the entire CDRH allotment to about $350 million. Clearly, there are things not being done that could be done. We think it’s because the resources are not there.

In terms of particulars, that question was asked of the CDRH director [Daniel Schultz, during his presentation at the MDMA meeting in May]. He had already presented his and the Bush administration’s priorities for CDRH. If more funding were available, he said, the priorities wouldn’t change, but the center could start and finish them sooner. [The priorities Schultz cited included beefing up postmarket surveillance, improving the center’s information technology, attracting more expertise to the review teams, and putting out more guidance.]

We will not substitute our judgment for FDA’s as to what the priorities are. FDA officials are the ones who know how to protect the American people the best. They just need more resources to do it.

Q: How did the alliance arrive at the $302 million figure (plus user fees) for the CDRH budget?

A: We recommend an overall increase for FDA of $450 million, to take its non-user-fee budget from just more than $1.5 billion in FY 2007 to $2 billion in FY 2008. Again, user fees are additional. Over the past five years, CDRH’s share of the non-user-fee, nonrent portion of the FDA budget has been about 17%. So the center was allotted that proportion of our proposed increase, and that was added to its FY 2007 budget. We arrived at the $2 billion number by looking at FDA’s responsibilities and what it costs to keep the agency at a functional and effective level every year.

The FDA budget needs to grow about 5.8% every year to break even. On a $1.5 billion budget, adding $90 million is breaking even. Anything less than that starts costing jobs. We took the FY 2003 number, added this break-even amount plus congressional mandates, most of which are directed but not funded. When you add those amounts in, you get to about $2 billion, so that’s what we’re requesting. This is in many ways a catch-up budget request rather than an expansive budget request.

Q: What should CDRH do with the extra funds if it is able to get them?

A: We will defer in each case to FDA and its center directors as to where the money is best used. What we know is that every time FDA does not get enough money, personnel slots (and people) disappear. CDRH is going through this. People are asked to do two, three, or four jobs, and they are not doing any of them as well as they should. One of the reasons we are asking for more money is to get more people. It is not the sexiest thing to be asking for, but it is the most fundamental. About 83% of the budget supports things like salary, benefits, and transportation.

Second, the IT situation at FDA is in need of major overhaul. Ideally, the overhaul should start with the e-mail system and then move to databases and adverse-event tracking. There are a number of daunting challenges in this area that require substantial investment.

Q: Have user fees helped the CDRH budget situation? Should they be increased in the future?

A: User fees have helped, and they are now a permanent part of funding the agency. Our concern is not whether user fees grow, but whether the core functions of the agency are adequately funded—to which user fees are supposed to be additive.

But there have been unintended consequences of user fees. The way the law is structured sometimes puts the [user-fee] money into places that are not necessarily the highest priorities within FDA. These triggers need to be updated and reworded, which I believe is being done in the current legislation.

Q: CDRH launched an ambitious Postmarket Transformation Initiative recently. Does the center have the funds to execute it properly?

A: I have no specific knowledge of how much that system will need or from where the funds will come. But I do know that postmarket surveillance is a concern for many programs within FDA. In general, there are not enough funds in the current budget to get the level of postmarket safety capabilities to the level that Congress and the public want them. More money is needed. Postmarket surveillance should be an asset to the agency instead of a question mark. Also, the results of the surveillance need to reach people sooner.

Q: What is the long-range plan for your organization? Will it stick around if FDA gets the budget increase you advocate?

A: From the beginning, we have envisioned that it will take about five years to get FDA where it should be. Therefore, we see a long-range need for advocacy. Even if we get everything we want this year, there will be needs next year, especially given the increasing complexity of the products the agency regulates. For example, more devices are becoming parts of combination products, which means different technological issues must be addressed.

Also, FDA has been a global standard for regulation, and that benefits the United States. That needs to be maintained, and advocacy is needed for the funds and infrastructure to make this a continuing reality.

So, yes, we expect to be here, and we expect FDA to need an outside voice on its behalf. There has certainly been success with outside groups helping NIH. Yet, the battle never goes away, even when you succeed. Although we have grown to 112 members as of June 2007, the bigger FDA Alliance is, the stronger it will be when it talks to Congress and the media about FDA’s needs. So we need to make it bigger and wider. It’s important that people make the commitment to stand up for these funding issues and become part of the effort to strengthen FDA.

Q: You have a lot of different voices in your organization. How do you balance their views?

A: That is an inherent challenge. Although we represent organizations with a broad range of interests and concerns, we are devoted to just a single mission. And that single mission is one on which our members are unanimous. The agency needs to be strengthened with more resources. We are careful not to get into policy issues that sometimes appear to be derivative from the budget issues. Those would wind up dividing our membership. We are sticking with one focused mission and it deserves all the attention we can give it.

– Erik Swain

Under an agreement between FDA and Health Canada, qualified auditing organizations (AOs) may perform third-party audits and inspections of medical device manufacturers’ quality systems. The results of these audits and inspections will meet both U.S. and Canadian regulatory requirements. A pilot multipurpose audit program (PMAP) opened last September. Officials from the two agencies said the pilot is a vehicle for further regulatory cooperation between the countries. They also expressed hope that the collaboration would lead to a reduction in the regulatory burden on the device industry.

Manufacturers participating in the PMAP gain an opportunity to be assessed by a single AO to both U.S. and Canadian regulatory quality management system requirements. “It is anticipated that this will reduce audit- and inspection-related interruptions in the workplace,” a CDRH program question-and-answer document said, “and result in resource savings for manufacturers.”

Because multipurpose audits and inspections are intended to satisfy different quality management system requirements, key indicators of PMAP success may include the level of manufacturer and AO participation. They may also include the ability of AOs to demonstrate that their preaudit inspection planning, documentation review, on-site assessment, and audit and inspection reporting still conform to the appropriate program requirements of both countries.

To be eligible to participate in the PMAP, manufacturers must

• Meet FDA and Health Canada definitions of a device manufacturer.
• Currently sell a Class II or III device in the United States that meets the U.S. definition of a medical device.
• Currently have at least one valid medical device license to sell a Class II, III, or IV device in Canada.
• Currently use the services of an AO that is both a Health Canada Recognized Registrar and an FDA Accredited Person.

Facilities an AO would visit during a multipurpose audit and inspection would include sites in North America and overseas where overall organization management takes place. In addition, sites where products are designed, where assembly takes place, or where products are packaged and stored would be eligible. Finally, sites where contract sterilization takes place, where outsourced processes related to the device are performed by suppliers to the manufacturer, and where device-related complaints and problems are received and reported on and device-related regulatory affairs are performed would be included.

Larry Kessler said at the Medical Device Manufacturers Association annual meeting in May that the basis for granting reciprocity to Canadian inspections lies in the fact that their inspectional criteria are based on the ISO 13485 standard, which is compatible with most FDA requirements. Kessler is CDRH science and engineering laboratories director. He also chairs FDA’s Global Harmonization Task Force.

Greater harmonization of inspectional criteria can result in reducing duplicative inspections, which has obvious advantages to both FDA and manufacturers. However, Kessler admitted the concept nevertheless presents a “double-edged sword.” For example, if problems were found with a product or manufacturing facility in one region, say Japan, it might result in interruption of marketing in the United States and Europe until the problem was resolved. He expressed confidence, however, that “leveraging the information and experience of foreign regulators” is a worthy effort, and that practical means may be found to overcome any associated downsides to this concept.

– James G. Dickinson

An objective reporter is supposed to keep his mind open and to tell both sides of the story. But after more than a decade of striving to do so in the case of CDRH enforcement, a tortuous trail of “no comments” and unanswered e-mails leaves me paraphrasing Hamlet: Something’s rotten in the state of FDA.I confess that I have failed to figure out what that something is. I know the symptoms but not the cause.

In case after case, the symptoms are the same. CDRH selects a small company for tough enforcement action on the basis of deficiencies in its documentation. There is no evidence of product defects or risk to public health, but CDRH demands so-called remedial action that would affect sales. The company, because it has no other revenue stream or because it feels outraged, pushes back. It wants to discuss the merits of FDA’s position. Something about the company’s demeanor or tone of voice angers someone at FDA. In response, CDRH causes prejudicial publicity that damages the company’s sales. CDRH resolves to teach the company a lesson by sticking to its guns, refusing to further explain or discuss the case. It issues more damaging publicity and becomes unresponsive to all substantive questions, whether from the company, its lawyers, or the media. Appeals to progressively higher levels in FDA only solidify CDRH’s original position.

This consistent enforcement behavior is only directed at small companies marketing FDA-approved specialty products. Things get p+ersonal quickly because the company’s survival is jeopardized by the agency’s demands. This behavior has produced a growing list of victims but has never, when brought before a federal judge, produced a single victory for FDA. Nevertheless, FDA recycles the same tactics year after year, as if unable to learn from its failures.

Companies that have bested FDA over the years include Bioclinical Systems (1988), Laerdal (1994), Myo-Tronics (1994), Andersen Products (1997), and Utah Medical Products (2004). Bioclinical Systems, though victorious, no longer exists. Laerdal closed its U.S. operation and moved overseas. Although Myo-Tronics is flourishing, Andersen was driven to the point of bankruptcy and will no longer talk about the case for fear of upsetting FDA. Utah Medical Products is waiting without much hope for FDA’s parent HHS to compensate it for the agency’s expensive errors.

All this is topical because the same CDRH enforcement strategy is currently playing against TMJ Implants (TMJI) and, until recently, was doing so against Shelhigh.

In the TMJI case, FDA has escalated to a civil money penalties claim for $630,000 before its administrative law judge. The company complains that the agency has refused to explain the medical basis for why TMJI needs to file MDRs for 17 patient events that the company says it has medically determined were not causally related to its devices. If filed, those MDRs would be posted on FDA’s Web site to be used against the company in the marketplace. As in other cases, FDA claims its reasonableness by telling the court about 18 communications with the company, as though actual dialogue between the parties had occurred. However, TMJI says FDA’s letters were only reiterations of FDA’s unchanging original position.

That position relies on FDA’s interpretation of the law and regulations, to which it says the courts should defer. In this case, FDA’s core position is that unless the device can be conclusively ruled out to be the cause of an event with 100% certainty, the event must be filed as an MDR. FDA’s position does not take into account the medical expertise of the reporter, the medical judgment of the firm, or the competitive harm that the firm might suffer. FDA’s two outside TMJ disease experts, both of whom admitted they had no experience with the company’s devices, concurred with FDA’s interpretation in each of the 17 events at issue. FDA complains repeatedly about the company’s “stubborn refusal” to file. However, it never addresses the company’s complaints about its own refusal to discuss the medical merits.

As TMJI’s final brief in the case said in June, it all boils down to a difference of opinion. But in such a disagreement, it is always FDA that is packing heat.

The Shelhigh case ended unexpectedly with the company’s capitulation in July. In that case, the tissue-based device maker had been subjected to mass media publicity over FDA’s concerns that its products may not be sterile. Shelhigh denied this, refused to conduct a recall, and complained that FDA would not discuss the scientific basis of its concerns. Nevertheless, in May the publicity caused Integra LifeSciences Corp. to recall all its Shelhigh-made EnDura No-React Dural Substitute products. Integra said it was notified by FDA that the agency classified its recall as Class 1.

Shelhigh also complained that FDA even refused to provide the company, or reporters, with a copy of the Health Hazard Evaluation the agency must fill out before ordering a product recall. According to Shelhigh, FDA said it should file a Freedom of Information Act request, whereupon the agency would likely still refuse to provide the evaluation on the grounds that it is part of an open investigatory file.

“The first questions to be answered in a Health Hazard Evaluation include a description of a defect, malfunction, or error in use of the device in question,” said Shelhigh marketing director Douglas Goldman before the company had settled. “Since there are no reported defects, malfunctions, or errors with Shelhigh devices of which I am aware, FDA doesn’t have facts to support its request for a recall,” he said. “FDA is acting irresponsibly and abusing its authority by continuing to claim that Shelhigh products present a health risk without presenting evidence.”

There are three common threads in all of these cases that are troubling. First, FDA uses publicity-generating tools to punish companies in the marketplace when they dare to push back. In the case of a small specialty company, negative publicity often endangers its continued existence. Second, FDA refuses to discuss the scientific and medical substance of its concerns with the targeted company or with anyone else before the matter reaches court. Finally, FDA produces no evidence to the target company or anyone else of product defects that might be a risk to public health.

If these tactics had resulted in an occasional victory for FDA in federal court, my mind might still be as open as it should be. Most puzzling is that, from my experience, none of the other centers within FDA behave in this way. The others seem to know that free and open discussion of the agency’s concerns among peers is the best way to promote healthy cooperation and to stay out of court.

– James G. Dickinson

The House appropriations bill including FDA’s budget that was passed last week includes an amendment that would end all conflicts of interest on FDA panels, the Boston Globe reports. The provision, attached by Rep. Maurice Hinchey (D-NY), would bar anyone with any financial ties to drug or device companies from sitting on FDA advisory panels.

The problem is, that would sharply reduce the pool of qualified experts. The reality of today is that many doctors and academics consult with or perform research for the drug and device industries. Whether this is appropriate for the drug industry is debatable, but it is most certainly necessary for the device industry. The success of a device is dependent on a caregiver’s ability to use it — which means they need to be involved at the product development stage.

FDA has already proposed a reasonable measure to curb the most egregious conflicts. Those receiving more than $50,000 from industry in the past year will not be allowed to serve, and those receiving between $1 and $50,000 may serve on the panels but not as voting members. A total ban is superfluous and unreasonable. Luckily, the Democrats in the Senate seem to understand this, and so Hinchey’s proposal will likely not survive when the chambers’ bills are combined.

– From MD&DI’s blog.

The House of Representatives has passed an appropriations bill that includes $1.8 billion for FDA’s FY 2008 budget, reports Bloomberg News. The figure is quite a bit more than the current budget, but short of the $2 billion that advocacy group FDA Alliance proposed. (More about its proposal can be read in the August issue of MD&DI.)

For archaic reasons (before FDA was created, food and drug safety was the province of the Department of Agriculture), FDA’s appropriation is part of the agriculture department’s. President Bush has threatened a veto because he thinks agriculture spending is too high.

The House’s bill will need to be reconciled with the Senate version when it passes.