Analysis: FDA chief grilled over testimony

ELLEN BECK, United Press International

WASHINGTON, March 11 (UPI) -- Food and Drug Commissioner Dr. Mark McClellan got the message loud and clear on Capitol Hill Thursday: He had angered lawmakers by failing to show up when summoned to testify on drug reimportation and he had better change his ways as he moves up the pecking order to run Medicare and Medicaid.

McClellan appeared before the Senate Commerce, Science and Transportation committee hearing to talk about specific plans FDA could use to approve the legal reimportation of prescription drugs from Canada and other countries. The appearance also provided senators and representatives -- Republicans and Democrats -- a podium from which to lecture McClellan about his responsibilities in light of his nomination to become administrator of the Centers for Medicare and Medicaid Services -- a far larger agency with the looming task of implementing a major Medicare overhaul and prescription drug benefit during the upcoming years.


No one was contesting McClellan's qualifications for the job -- he is a physician and an economist and seen as a person who works well with both political parties. Although the criticism was not aimed at blocking his approval by the full Senate, it was clear some lawmakers found his actions at FDA on drug reimportation less than satisfactory.


It also was clear the move to allow reimportation is gaining a stronger foothold in Congress.

Sen. Byron Dorgan, D-N.D., told hearing attendees -- while McClellan listened quietly -- the FDA commissioner had been requested at least twice to appear before the committee to discuss reimportation.

"Not only the U.S. Senate -- but the House has also requested Dr. McClellan to testify. He has refused," Dorgan said. "My mission is not to stop or start any nomination (but) no one in this government can ignore Congress if they're asked to testify."

Sen. Trent Lott, R-Miss., said McClellan should testify "when he is requested to appear and I don't think this administration or any administration should refuse to do that."

Lott said he has decided to change his position on reimportation and will support it because he just could not explain to his mother why her drugs cost so much more in the United States than they do in Canada.

Reps. Dan Burton, R-Ind., and Bernie Sanders, I-Vt., added criticism from House.

Burton, and other members of the House Market Access Coalition, recently had sent a letter to the Senate Finance committee, which has approved McClellan's CMS nomination, outlining their concerns that he failed to show up to testify at hearings of the Subcommittee on Human Rights and Wellness.


"I held four hearings in 2003 to examine this issue, and we invited Commissioner McClellan to testify at two of those hearings," Burton wrote. "On both occasions Commissioner McClellan declined, preferring instead to send Mr. William K. Hubbard, FDA associate commissioner of policy and planning. Most recently, I personally reached out to Commissioner McClellan, and invited him to appear before my subcommittee next month. And once again, my request was flatly rejected."

Burton said McClellan has since refused to send any FDA representatives to reimportation meetings.

"Not only would he not appear before out committee, he would not return our phone calls," Burton told the committee, adding although he did not want to criticize McClellan's confirmation, a person of "authority" in the government should appear when asked. "I hope Dr. McClellan in the future will comply with requests from Congress to testify," he added.

"Any member of the administration, in any party, should come before Congress should defend what he or she is doing," Sanders said.

McClellan apologized and said he just realized it was a problem a couple of weeks ago.

"My own view of what you have done," Dorgan said during questioning, "you have been aggressive in trying to prevent the reimportation of drugs. ... Why haven't you testified?"


"I am very pleased to be here today to present our agency's view," McClellan responded.

"That's not what I asked," Dorgan shot back.

"FDA has testified every single time we've been asked," McClellan said. "When committees have requested our testimony we have always produced."

Dorgan continued to push McClellan on why he, personally, did not show up -- in particular because he was aspiring to the job of CMS administrator.

"This has been a very informative confirmation process," McClellan said. "We tried very hard to make sure we had a witness at every hearing ... I'm very sorry about the perception that we haven't been responsive. When I'm asked to testify, I will be there."

"That's a bit disingenuous," Dorgan said, and added a FDA staffer told him McClellan was testifying Thursday only to reverse a trend of politics over process.

"I intend to be here when you request," McClellan said.

McClellan reiterated earlier statements that he wanted to work with Congress to develop ways to ensure the safety of reimported drugs and their cost savings to U.S. seniors.

Many seniors have been traveling to Canada or Mexico to buy U.S. drugs far cheaper than they cost in the United States. States and cities also are looking at reimporting drugs for their employees to save money during tight budgets.


McClellan stuck to the FDA's position, however, that the agency does not now have the financial or personnel resources to establish a widescale program to monitor, inspect and ensure reimported drugs are not counterfeit, diluted or improperly stored -- problems that could pose health threats to users.

Committee Chairman John McCain, R-Ariz., said any new legislation allowing reimportation "must contain safeguards that protect American consumers from counterfeit or tainted drugs."

Sen. Ron Wyden, D-Ore., questioned McClellan on how much it would cost to set up a FDA system to monitor and assure the safety of reimported drugs.

McClellan said although hundreds of millions of dollars have been budgeted to ensure safety of the incoming U.S. food supply, a "relatively small amount -- a few million dollars" is spent on doing the same for legally imported drugs.

He said an FDA program for drugs potentially could cost even more than what USDA is spending on food, depending on how many countries and how many drugs were involved. He added FDA did not have a specific plan at the moment but was looking to reach bipartisan agreement with Congress about the best approach.

"I'm absolutely willing to work with Congress to find the answer," McClellan said. "We want to be flexible in working with Congress to address these safety concerns."


McCain said one answer to reducing drug costs outside of reimportation was to allow the secretary of Health and Human Services to negotiate with drug manufacturers to ensure the lowest price for drugs for the Medicare program -- something directly prohibited by the new Medicare law.

McCain repeatedly asked McClellan if he supported that provision of the bill. McClellan replied he supported provisions in the bill to reduce drug costs while ensuring safety. McCain was not satisfied, however, and pushed the issue.

"I support the overall legislation, including the provisions in it," McClellan answered.


Ellen Beck's e-mail is

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