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Acting FDA commissioner Joshua Sharfstein has made his presence felt during his few months in office. His latest move is to ban the use of gift cards and other informal bonuses to FDA employees. Last year, about 15% of FDA employees received gift cards. But after a report surfaced that the agency had a $41,030 contract with a company to supply gift cards, Sharfstein thought it would be wiser to hold off on them. CDRH had made arrangements to buy 160 cards at a rate of $250 per card.

“My perspective is, we’re the new team coming in. We are responsible for how the agency money is being spent,” Sharfstein said. “It’s really important that we’re comfortable” with such incentives.

During this period of intense FDA scrutiny from all sides, it’s probably not a bad move.

Margaret Hamburg will be sworn in as FDA commissioner later this week. She was confirmed by the Senate on Monday and will likely join the action—including how and whether to develop a swine flu vaccine—next week. As expected, acting commissioner Joshua Sharfstein will be deputy commissioner.

Three federal appellate judges from the Tenth Circuit heard oral arguments on March 9 in TMJI’s appeal of $340,000 in civil money penalties for not filing MDRs for 17 events. They seemed skeptical of HHS and FDA processes that led to the case. All Republican appointees in the Denver-seated courthouse, they asked nearly three times as many questions of the Department of Justice attorney, Peter Maier, as they did of the company’s attorney, Lynn Watwood.

Senior judge and Reagan appointee David Ebel was concerned about the due process FDA had afforded the company. He observed that 21 CFR Part 10 does not preclude the agency from proceeding with an enforcement action during an appeal, but noted that it does not authorize progression of such an action to imposition of civil money penalties. In questioning Watwood, Judge Ebel wanted to know how TMJI had “read into” a letter from CDRH director Daniel Schultz that a pending appeal meant no enforcement action.

Reagan appointee Deanell Reece Tacha asked whether TMJI had been lulled into complacency by the letter it received from Schultz, which stated that its protests were being treated as an appeal and being handled by the Office of the Commissioner. Maier retorted: “To their peril!”

Watwood responded that the earlier warning letter TMJI had received demanding the MDRs came from “a lower branch, i.e., CDRH. It was only an opinion from that lower branch and not final disposition of that dispute.” FDA has repeatedly argued in previous cases that appeals can only be disposed of by the commissioner. Watwood further stated that, consistent with FDA’s position in earlier court cases, Schultz had said that he would personally treat further communication by TMJI as an appeal to the commissioner for his ruling. However, Watwood said, the record shows that before the commissioner could rule on the appeal, the company was served with the civil money penalties order. —James G. Dickinson

Margaret Hamburg is said to be President’s Obama’s choice for FDA commissioner, according to the Los Angeles Times. The agency has been without a leader since Andrew von Eschenbach resigned in December. If confirmed by the Senate, Hamburg will have to confront such issues as a recent GAO report that says FDA is not properly reviewing medical devices and complaints by some agency scientists about a corrupted review process.

The 53-year-old Hamburg is a former New York City health commissioner, a physician, and a bitoterrorism expert. It is expected that she will be assisted by Baltimore health commissioner Joshua Sharfstein—Obama’s likely pick for deputy commissioner, according to Bloomberg. Sharfstein is a pediatrician, who led Obama’s transition team’s assessment of FDA. He also served as an aid to Rep. Henry Waxman, an often vocal critic of the device industry.

Ray Woolsey, president of the Critical Path Institute, tells Bloomberg that, “FDA is a public health agency and to have two public health leaders at the helm is a clear signal of the right direction for the agency.” Of course, no matter how committed Hamburg and Sharfstein are to reform, great leadership may not be enough to overcome the agency’s severe lack of funds. “The agency is regulating 25% of everything we touch every day, and it has a budget that hasn’t gone up in 20 years,” Woosley tells Bloomberg.

The sprawling 662-acre plot of land in White Oak, MD, has seen better days. If not better, then at least busier ones. But that will change with FDA’s migration to the area. What was once the Naval Surface Warfare Center in White Oak, a suburb of Washington DC, will now house FDA operations. Some departments have already moved in (3700 employees are there already), but the campus is undergoing a makeover for FDA’s purposes. Six new buildings have been constructed and two more are on the way. The government has spent $680 million on the renovation project so far (the entire project is expected to cost $1.15 billion, including 14 new buildings and 3.1 million square feet of labs and offices). Although there doesn’t appear to be a hard deadline for this transition, the White Oak facility is expected to house more than 8800 FDA employees by 2012.

Following a reveal that Tom Daschle owed $128,000 in taxes, the senator withdrew his nomination yesterday as the next Health and Human Services Secretary. The former Senator from South Dakota had failed to pay taxes on the use of a free car and driver, provided by a Democratic fundraiser. Daschle, concluding that he owed the taxes, filed amended returns and paid more than $140,000 in back taxes and interest on Jan. 2, 2009.

So now the question. Who is a possible replacement nominee for the office in HHS? Daschle’s withdrawal not only puts the Obama administration in a scramble to find a suitable pick, but it will likely delay the appointment of a commissioner for FDA. Although there was not a permanent commissioner for most of President George W. Bush’s two terms in office, the White House says that finding an HHS secretary and an FDA commissioner remain high priorities. AdvaMed expressed its disappointment with Daschle’s withdrawal but urged the current administration to press on.

“We urge President Obama to move quickly to name a replacement nominee to fill the crucial position of Secretary of HHS,” said AdvaMed president Stephen Ubl in a statement, “so that work can proceed to reform the U.S. health care system so that all Americans can benefit from affordable, quality insurance and the best that medical innovation has to offer.”

A short list of names has floated around, but the White House says that the president is very close to announcing his selection to lead the beleaguered agency. In the coming days, President Barack Obama will announce his pick for FDA commissioner, according to one of his spokesmen.

“The president hopes in the next few days to announce a pick for commissioner at FDA,” White House spokesman Robert Gibbs told a press briefing.

As seen from a recent inquiry, Senator Charles Grassley doesn’t mind holding FDA and manufacturers accountable for any possible unapproved devices (or unapproved uses). Grassley’s name has popped up quite a bit in medical device regulatory matters:

*He fought against Andrew von Eschenbach being confirmed as FDA’s commissioner.
*He proposed a bill that, among other things, would give FDA more authority to require postmarket studies and penalize firms that fail to complete them.
*He pressed CDRH on looking into Guidant’s defibrillator problems.
*He asked von Eschenbach to investigate the investors of the start-up company that developed the Prodisc device manufactured by Synthes.
*He sent a letter to the Cardiovascular Research Foundation requesting information about its financial relationship with Abbott Laboratories and four other companies.

A penny for Grassley’s thoughts on transforming the agency…

A call from a legislator may have prompted FDA officials to override scientists and approve the sale of an imaging device for breast cancer according to agency documents, reports the New York Times. This is the latest is a long line of allegations by FDA scientists who feel officials are shepherding medical devices through approval regardless of scientific evidence for efficacy.

The House Committee on Energy and Commerce has begun its investigation, thereby making documents such as e-mails that highlighted the phone call public.

In the documents, the Times reports that former representative Christopher Shays, (R–CT) is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that helps radiologists detect breast tumors. The device in question was the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, used with screening equipment from Fujifilm Medical Systems.

Mr. Shays told the paper that he called the agency supervisor only to demand that it make a final decision, not that it approve the product. Fujifilm Medical spokesperson, Courtney Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the FDA process.”

Although it’s really FDA that is in the hot seat, industry should prepare itself. We should expect more such allegations, and without the cushion of redaction to protect the names.

A group of federal scientists is complaining of widespread managerial misconduct in FDA’s Center for Devices and Radiological Health (CDRH), according to the Associated Press. The scientists wrote a letter to the Obama transition team, saying, “The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” said the letter, dated Wednesday and written on the agency’s CDRH letterhead. A copy of the letter, with the names of the scientists redacted, was provided to AP by a congressional official.

According to AP, the letter alleges that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx. FDA declined to publicly respond to the letter, but said it is working to address the concerns.

“Managers with incompatible, discordant, and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts,” the letter said. “Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid.”

AP says that the letter singled out mammography computer-aided detection devices as an example of a technology that should not have gone forward. The devices were supposed to improve breast cancer detection, but instead studies showed they were associated with false alarms that led to unnecessary breast biopsies.

Since 2006, FDA experts have recommended five times against approving the devices without better clinical evidence, the letter said. In March of last year, a panel of outside advisers supported some of the concerns of the FDA’s in-house scientists. Nonetheless, FDA managers overruled the objections and ordered approval.