FDA Commissioner Andrew von Eschenbach admitted to Congress that the dispute over TMJ Implants’ appeal of a warning letter was “a process failure,” and said the agency is currently reviewing its procedures for handling disputes and appeals of warning letters, HealthImaging.com reports. An assistant commissioner is leading the review. The commissioner said FDA staff will follow up with the House Oversight and Investigations Subcommittee staff when the new procedures are in place.
Reps. Dan Barton (R-TX) and John Shimkus (R-IL) sent an angry letter to von Eschenbach last month over the treatment of TMJ Implants. CDRH issued a warning letter to the firm for not filing 17 Medical Device Reports, but the company disputed that MDRs were warranted. The firm says its appeal was never substantively reviewed before an FDA administrative law judge ruled against it and ordered it to pay $630,000 in fines.
– From MD&DI’s blog.
May 9th, 2008
Sen. Herb Kohl (D-WI) has amended an emergency supplemental appropriations bill to add $275 million in funding for FDA, WisPolitics.com reports. Kohl, chairman of the Chairman of the Senate appropriations subcommittee that has jurisdiction over FDA, said he has “serious concerns” about the agency’s ability to do its job with present funding. Of the total funding in the bill, $125 million is for food safety activities; $100 million is for medical product and drug safety activities; $40 million is for modernizing FDA science and the FDA workforce; and $10 million is to upgrade FDA facilities and laboratories outside of Washington, DC.
The Alliance for a Stronger FDA welcomed the news. “By placing additional funding in this year’s emergency supplemental bill, Senator Kohl has highlighted the size and urgency of FDA’s needs,” said association President Wayne Pines.
Whether the amendment survives the final mark-up of the bill will be determined next week.
May 8th, 2008
FDA said yesterday that it wants to fill more than 600 new positions and more than 700 vacant ones by October, triple the number of people it hired between 2005 and 2007. This comes in response to rampant criticism of lax oversight and lack of specialists who are able to keep up with the latest technological advances. Hires will include biologists, chemists, medical officers, statisticians, epidemologists, and others, reports the Associated Press. About 150 will be inspectors, as the agency’s understaffed inspection team has come under fire recently.
This is just the beginning. 30% of FDA staff is eligible to retire, as is almost half of FDA management. Word on the street has been that many will choose to retire rather than move to the agency’s new White Oak facility when that is finally ready to be fully operational.
The agency will be holding job fairs around the country and has received permission from the Office of Personnel Management to expedite the hiring process.
– From MD&DI’s blog.
May 1st, 2008
FDA Commissioner Andrew von Eschenbach says that it is misleading to get caught up in the numbers when it comes to assessing how often foreign device and drug plants that make products for the United States should be inspected. He told Bloomberg Television that foreign inspections should be risk-based, just like domestic inspections are. That means plants that make high-risk devices or have a history of noncompliance could be inspected more than once every two years, while plants that make lower-risk devices and have good compliance records could be inspected at a less frequent rate.
Also importantly, he said FDA needs to share data with other countries to help each agency determine which plants are in most need of frequent inspection. He especially envisions such collaboration in countries like China, which have immature regulatory systems.
April 28th, 2008
The Government Accountability Office says FDA’s plans to boost foreign inspections of drug and device plans don’t go far enough, reports the Star-Ledger of Newark, NJ. Congressional Democrats agree, and two of the party’s leaders in the House chided FDA Commissioner Andrew von Eschenbach for not doing enough to fix a system that led to, among other things, contaminated heparin from China reaching U.S. shores.
The GAO said it would take $67-71 million per year to inspect just the foreign drug plants that make products for the U.S. in a timely manner — never mind medical device and food plants – but FDA has only committed $11 million for all foreign inspections this year, and $13 million next year.
von Eschenbach said he has asked for more money to conduct foreign inspections, but did not say how much. He added that increasing inspections will not solve the problem by itself. “I don’t believe that’s the solution to the problem,” he told Congress. “It’s much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility. I believe we are making progress, but the problems are substantial, and they require substantial effort.”
April 23rd, 2008
A bill proposed in the House of Representatives would require all medical devices being imported into the United States to be labeled with their country of origin, reports the Associated Press. The bill would also create a permanent foreign-inspection staff for FDA and mandate that overseas device and drug plants be inspected every two years. These measures are spurred by a slew of recent reports about tainted products from China, including a recall of heparin, which is used as a medical device coating.
Also of significance is that the bill contains language that gives FDA the power to force recalls. Currently, they can only suggest that a manufacturer conduct a recall. The vast majority of the time, the manufacturer complies.
– From MD&DI’s blog.
April 18th, 2008
A draft guidance outlining how companies can distribute journal articles that discuss unapproved uses of FDA-approved devices is being greeted with open arms. It marks the first time that the agency has considered allowing manufacturers to mention off-label uses to physicians in any way.
FDA’s Good Reprint Practices document suggests how device firms should disseminate scientific or medical journal articles and reference materials that talk about off-label device use.
“It’s significant because it shows that FDA recognizes there’s a legitimate zone of communication between manufacturers and the healthcare industry regarding truthful and nonmisleading materials on off-label uses,” says Pamela Furman, partner at King & Spalding LLP (Washington, DC).
Overall, the proposed guidance has been praised within industry, but opponents have criticized FDA for letting companies promote potentially unsafe, unapproved uses of devices.
In a November 30, 2007, letter to FDA commissioner Andrew von Eschenbach, Congressman Henry Waxman (D–CA) wrote that the “ill-advised” guidance would create a “large loophole in the law and create a pathway by which drug and device manufacturers can promote unapproved uses of their products without first obtaining FDA approval.” (The document was not made public until this February, but Waxman saw an internal version of it last October.)
Although there may be potential for abuse, the draft offers guidelines for the types of acceptable articles and how they should be distributed.
“This is not really a loophole,” says Jonathan Kahan, partner at Hogan & Hartson LLP (Washington, DC). “If you look at FDA’s criteria for disclosing here, it has to be a peer-reviewed journal article or textbook, and there has to be full disclosure that it includes off-label information. Therefore, I think as long as it’s not false and misleading and there is full disclosure, it can actually significantly benefit the patient.”
According to FDA spokeswoman Rita Chappelle, the agency proposed the guidance to clarify its current thinking on what constitutes a good reprint. The guidance on reprints was contained within section 401 of the FDA Modernization Act of 1997, which expired in September 2006.
“By issuing this guidance, FDA hopes to clear up any confusion about our thoughts on this and also hopes to provide guidance on what would constitute a safe harbor from current laws,” says Chappelle. Further, she explains, it enables FDA to begin enforcement action against firms that operate outside of the principles laid out in the guidance. Chappelle adds that the agency retains the legal authority to decide whether the distribution of material promotes an unapproved new use or whether such actions cause a product to be considered misbranded or adulterated.
“The guidance is not an open season to spread off-label information. It’s very specific to truthful, educational information,” says Robert Klepinski, an attorney at Fredrikson & Byron P.A. (Minneapolis). He explains that in releasing the guidance, FDA has acted pragmatically and recognized the state of the law.
In addition to being peer reviewed, articles must reveal any conflicts of interest and must be published by an organization that has an editorial board. The draft recommends against distributing materials that have been funded by manufacturers of the product in the article.
Doctors and other users now have instant access to articles via Internet. Kahan says that it’s valid for companies to provide truthful and correct documents about off-label device uses when approached by doctors. “Not only should the company be able to do that, they probably [also] have an obligation, so that the doctor fully understands from the journal article what’s being done and how the device is being used.”
To adhere to the guidance, companies should employ a standard operating procedure (SOP) to help train employees, Klepinski advises. “People are going to need an SOP to control how they train the sales force in how to follow this guidance and the in-house employees in executing it.”
Klepinski’s only criticism of the draft is the labeling recommendations, which are supposed to accompany the journal reprint or reference material. He says the labeling section is either too vague or too detailed, depending on the recommendation.
Furman also feels that more clarification is needed. For example, she says, FDA requires a disclaimer or disclosure attached to any materials for which there is a risk or safety concern posed by any unapproved use that is significant and known to the manufacturer. “I think that’s a subjective notion and can sometimes be a tough call,” Furman says.
Klepinski agrees, adding that it puts a big burden on manufacturers. “The purpose of these articles is to tell one doctor what another doctor is doing. The manufacturer isn’t going to know, by definition, all of the risks—they haven’t done this research.”
Furman and Klepinski expect other stakeholders in industry to express concern over the labeling issues as well. FDA is accepting public comments on the draft guidance until April 21. A copy of the document is available on FDA’s Web site.
– Maria Fontanazza
April 17th, 2008
FDA is making a pitch to the U.S. Sentencing Commission for more-stringent maximum sentences. The commission is considering new sentencing guidelines.In February, FDA assistant commissioner for accountability and integrity William McConagha told the Sentencing Commission that it should determine the adequacy of the existing guidelines for the Federal Food, Drug, and Cosmetic Act (FD&C Act), which covers medical devices.
“We at FDA believe that establishing an appropriate penalty framework for violations of…[the FD&C Act] is critical to provide a specific and general deterrent to crimes that threaten…the public health,” McConagha testified. “For that reason, we believe that realistic sentencing guidelines for these offenses are of vital importance to the agency’s public health mission.”
He said that the current guidelines are inadequate to address the significant public health consequences of various FD&C Act offenses. Most FD&C Act offenses, he said, involved adulterated or misbranded products.
Products, he said, can be adulterated or misbranded for many reasons set forth in the FD&C Act. The existing sentencing guidelines don’t directly address whether misbranded or adulterated FDA-regulated products can be viewed as having value when loss is calculated. So McConagha suggested revising the guidelines to provide that, in those cases, loss would include the amount paid for the product with no credit for a product’s purported value.
That proposal drew fire from attorneys at the Washington, DC–based law firm of Hyman, Phelps & McNamara, who said it “raises many questions and concerns. First, creative lawyers in the context of civil litigation may try to employ FDA’s proposed finding to seek a monetary recovery based on that
calculation.
“Second, the change would almost certainly dramatically increase sen-tences to be imposed in cases where loss is at issue, including all felony cases.
“Third, if adopted, it may make it very difficult for companies and individuals to work out guilty pleas with the government because the guidelines will warrant a sentence that the defense will find intolerable.”
The firm’s FDA law blog says FDA’s position is “breathtaking in its scope.” The attorneys note that every day, many manufacturers distribute products that are not in full compliance with all FD&C Act mandates and thus are technically adulterated and misbranded. Such distribution routinely occurs with FDA’s knowledge, the blog says. To say that all adulterated and misbranded products are worthless “raises serious legal and policy issues that the commission should fully explore before adopting FDA’s suggestion.”
John Fleder, a director in the law practice, said there is “no evidence that the system is broken or that the proposed changes…are necessary or appropriate based on the FD&C Act statutory scheme, the purposes of the guidelines, or the actual record of FD&C Act criminal enforcement.”
– James G. Dickinson
April 17th, 2008
In case you were wondering whether FDA was going to learn from its loss in court to Utah Medical, the answer is apparently no.
Just as with three previous agency defeats in federal court, the Utah Medical case has been omitted from The Enforcement Story, the agency’s official public report of significant legal decisions, which is published annually by the Office of Regulatory Affairs (ORA).
The Utah Medical case is legally significant because it established that, in quality system regulation or GMP compliance, a medical device company is free to depart from the prescriptive direction of FDA officials—that “many roads lead to Rome.” In other words, government enforcement of penalties requires officials to identify which Code of Federal Regulations requirements are being violated by a device firm, not dictate methods that a company must use to comply with those regulations.
In normal circumstances, such guidance from the federal judiciary could lead to a change in agency practices. The current practice is one of prescribing “how to” advice to industry, through workshops, speeches, informal advice, interpretive guidances, and other means, as opposed to “what to” advice.
However, shortly after the Utah Medical decision was handed down, a senior FDA attorney was reputed to have said, informally among other lawyers, that the decision was delivered by an “aberrant” judge. (Utah Medical judge Bruce S. Jenkins, who was appointed by President Carter in 1978, actually has a long list of home-state accolades and honors to his credit.)
Since then, no FDA or Department of Justice attorney associated with the case, or any other federal official, has been willing to discuss the case, either on or off the record. Because most professional legal forums in what is known as the “FDA bar” rely heavily on the fraternal participation of FDA attorneys, that reliance effectively discourages anyone from discussing this case in formal programs. It’s as if it has simply vanished.
When I reported on Jenkins’s record in January on FDAweb.com, it attracted a sneering anonymous comment from someone who seemed to be familiar with the case from FDA’s perspective. “These plaudits all come from the judge’s alma mater or the Utah [State] Bar. Utah is well known as a rogue state with uber-libertarian sentiments regarding federal regulation of any kind, and that sentiment is even more prevalent in the realm of drug, device, and dietary supplement regulation.”
Two separate requests for an explanation for the omission from ORA’s most responsible officer, associate commissioner for regulatory affairs Margaret O’K. Glavin, garnered no response.
Apparently, in FDA’s mind, this “aberrant” and inconvenient truth never was.
In an agency over which commissioners may reign but not rule, as reported last month, why should we be surprised if, below these nominal commissioners, subordinates may overrule the orders of judges?
– James G. Dickinson
April 17th, 2008
Members of a Senate appropriations subcommittee yesterday declared that FDA needs a significant increase in funding in order to accomplish its mission, and asked FDA Commissioner Andrew von Eschenbach to estimate how much of an increase the agency could absorb without logistical problems, reports the New York Times. After the Senate passed a resolution calling for a 20% increase in FDA’s budget, von Eschenbach said the agency would have trouble absorbing that much of an increase in one year. So Sens. Herb Kohl (D-WI) and Robert Bennett (R-UT) asked him to estimate how much the agency could absorb in one year. He said he would be happy to present them with a series of options at a later date. He also said he wants to hire about 700 people next year, but would not be able to do so if President Bush’s budget proposal were adopted unchanged.
The commissioner sounded more optimistic about the agency’s ability to accomplish his mission than he had previously, however. In a speech last month, he said that FDA may fail in its mission because of funding. Yesterday, he said that FDA remains the gold standard of food, drug, and device regulation, but that it must change if it wants to maintain that level.
– From MD&DI’s blog.
April 16th, 2008
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