Posts Tagged ‘Labor and Pensions Committee’

Senate Passes Bill to Fund the FDA

Wednesday, June 6th, 2012

In a rare show of bipartisanship, the Senate voted 96 – 1 to fund the Food and Drug Administration (FDA), a regulatory powerhouse with far-reaching influence over the foods Americans eat and the medicines they take.  The bill’s goal is to speed approval of new drugs and devices and ensure food safety.  It reauthorizes fees from companies like Johnson & Johnson, Medtronic, Inc. and Roche Holding AG that facilitate FDA evaluation of new medical products prior to approval.

These user fees could provide approximately 50 percent of the FDA’s proposed $4.5 billion budget for 2013.  The FDA regulates products that make up nearly 25 percent of the American economy.  Similar legislation has passed a House committee with support from both sides of the aisle and may move to the full House for a vote quickly.  Senate leaders sped the bill through the chamber, emphasizing its importance in protecting consumer safety and promoting innovation in medicine.

“This bill is a shining example of what we can achieve when we all work together,” said Senator Tom Harkin (D-IA), who chairs the Senate committee that oversees the FDA.  Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the American market but must be renewed every five years.  The current version will expire in September.  Additionally, for the first time the FDA will also collect fees from makers of generic drugs and of copycat versions of complex biotech drugs, known as biosimilars.  “We’ve worked on this bill for 18 months,” Harkin said as he and ranking member Mike Enzi (R-WY) refereed the mostly cordial debate.  The two led opposition to all of the amendments that came up for a vote, and all were defeated.

Senator John McCain (R-AZ) proposed an amendment that would let Americans import drugs from approved Canadian pharmacies.  “In a normal world, this would require a voice vote,” McCain said.  “But what we’re about to see is the incredible influence of special interests here, particularly (the Pharmaceutical Manufacturers Association).”  Senator Robert Menendez (D-NJ) argued that it’s not about the special interests.  “It’s about the health and security of the American people, which is why time after time the Senate has rejected it,” Menendez said.

Senator Bernie Sanders (I-VT), who cast the sole “no” vote, got a vote on his amendment to take away exclusive marketing rights from drug makers if a company is found to be at fault for fraud involving a particular drug. The measure failed overwhelmingly, 9-88.  “Almost every drug company in this country is perpetrating fraud,” Sanders said.  “They’re ripping off Medicare; they’re ripping off Medicaid; and they’re ripping off the American consumer.”

The bill’s speedy passage surprised onlookers accustomed to the usual congressional gridlock.  “I haven’t seen anything move this fast in a long time,” said Lisa Swirsky, a senior policy analyst at Consumers Union.  “Congress is actually working.  It’s kind of like you learned about it in high school.”  Nevertheless, consumer advocates have mixed feelings about the Senate bill that now goes to the House.  “If you look back at what we saw in the House in December, you know this could have been a lot worse,” Swirsky said. She noted that she was “deeply disappointed” that some provisions consumer groups were pursuing to toughen FDA’s review of medical devices did not make it into the bill.  “I would say it’s bittersweet but mostly bitter.”

For more than seven decades, the FDA has primarily inspected U.S. factories.  In recent years, pharmaceutical companies have moved their operations overseas to take advantage of cheaper labor and materials.  Between 2001 and 2008 the number of American drugs made overseas doubled, according FDA figures.  Today approximately 80 percent of the ingredients used in U.S. medicines are made in other countries.

The Senate bill will end a requirement that the FDA inspect all American factories every two years, and give the agency increased discretion to focus on foreign facilities.  At present, the FDA inspects the typical foreign manufacturing facility once every nine years.  Under the bill,  FDA inspectors will target the most problematic manufacturing sites, no matter where they are located.  “This puts domestic and international facilities on an even playing field for the first time,” said Allen Coukell of the Pew Charitable Trusts, which has advocated for increased drug safety.  “It says to FDA, ‘you should inspect the highest risk facilities first, no matter where they are in the world.’”

“These are all the steps American families already think we have in place to protect them,” said Senator Michael Bennet, (D-CO), one of the bill’s authors.  “I cannot tell you how many town halls I have had where people have been shocked to learn that the products they have in their medicine cabinets have never been inspected.”

Senate Republicans Refusing to Confirm Dr. Donald Berwick

Monday, March 14th, 2011

Senate Republicans are trying to block the nomination of Harvard-educated pediatrician Dr. Donald Berwick to serve a full term as the administrator of the Centers for Medicare and Medicaid Services.  Led by Senators Orrin Hatch (R-UT), the ranking member of the Senate Finance Committee, and Mike Enzi (R-WY), the ranking member of the Senate Health, Education, Labor and Pensions Committee, the senators contend that President Barack Obama’s recess appointment last year was completed before a hearing was held.  The senators contend that this hindered the 111th Congress’ ability to fully consider Berwick’s nomination.

“This abrupt and unilateral action meant that no senator — Democrat or Republican — was given the opportunity to ask Dr. Berwick a single question before he was placed in charge of an agency with a budget larger than the Department of Defense; which controls four percent of our nation’s gross domestic product; and, most importantly, directly impacts more than 100 million American lives every single day,” according to the Senators’ letter.  The senators say that Berwick’s “past record of controversial statements, and general lack of experience managing an organization as large as complex as CMS should disqualify him” from the post.  “Once you have withdrawn his nomination, we are confident we can all work together to find a nominee for administrator we can support and confirm after appropriate hearings are held,” the letter stated.

Even some Congressional Democrats are urging the Obama administration to find another Medicare chief after concluding that the Senate is unlikely to confirm Dr. Berwick. The most-favored nominee is Dr. Berwick’s principal deputy, Marilyn B. Tavenner, a nurse and former Virginia secretary of health and human resources who has extensive management experience and would likely be confirmed.  President Obama bypassed Congress and named Dr. Berwick to his post while the Senate was in recess last summer.  The current appointment allows him to serve to the end of 2011.

Despite the vocal opposition to Dr. Berwick, President Obama is refusing to withdraw his nomination. “The president nominated Don Berwick because he’s far and away the best person for the job, and he’s already doing stellar work at CMS: saving taxpayer dollars by cracking down on fraud, and implementing delivery system reforms that will save billions in excess costs and save millions of lives,” White House spokesman Reid Cherlin said.  Unfortunately for the president, even some Senate Democrats believe that Berwick cannot be confirmed.  Senate Finance Committee Chairman Max Baucus (D-MT) has said that he would not commit to a confirmation hearing, and other Democrats have acknowledged that the nomination is in trouble.  “I think it would be very tough in this environment.  If we can get some bipartisan products moving forward, then the answer is yes. If you can’t get some bipartisan products moving forward, it’s going to be difficult,” said Senator Ben Cardin, (D-MD).

The Medicare administrator’s job involved significant responsibilities under the healthcare law, such as establishing new insurance markets, expanding Medicaid, and overhauling the way Medicare pays providers to reward quality instead of volume. Republicans need 41 votes to block Berwick’s confirmation in the full Senate; their letter indicates they have more than enough.  The loss of Berwick, a respected medical innovator and patient advocate, would be a blow to the administration as it moves ahead in its implementation of the healthcare reform law.

Five Republican senators did not sign Hatch’s letter.  They are Scott Brown (R-MA), Susan Collins (R-ME),  Olympia Snowe (R-ME), Lisa Murkowski (R-AK), and Rob Portman (R-OH).