Posts Tagged ‘education’

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.”

New Study Ranks Healthiness in the Nation’s 3,016 Counties

Tuesday, April 19th, 2011

A study led by the Robert Wood Johnson Foundation has ranked the level of healthiness in the more than 3,000 counties that comprise the United States. Conducted with the assistance of the University of Wisconsin’s Population Health Institute, the study entitled “County Health Rankings: Mobilizing Action Toward Community Health,” provides a snapshot of where America’s healthiest people live.

“This is a complicated story about what makes a community healthy and another not so healthy,” said report author Pat Remington, the associate dean for public health at the University of Wisconsin.  For example, researchers point to cities reputed for their top-quality medical centers – most notably Baltimore and Philadelphia — that ranked close to the bottom in their respective states.  “Social, economic and health habits may be at play there,” said James Marks, senior vice president and director of the foundation’s health group.

The researchers examined federal and state health-related data on 3,016 counties, according to Remington.  The information was analyzed by researchers who had created similar reports for the state of Wisconsin over the past six years.  Remington said   his group wanted to “bring it down to the ground level” by learning where strengths and weaknesses lie within individual counties.

Each county is examined in two ways:  “Health Outcomes” and “Health Factors.”  “Health Outcomes” look at a county’s disease and death rates.  The “Health Factors” rating is more complicated and examines such factors as obesity rates, smoking and alcohol use.  Socio-economic factors, such as unemployment, income and safety, also are considered in addition to access to healthcare and the local environmental.  “The ‘Health Outcomes’ rank is about current healthiness factors.  The ‘Health Factors’ rank is about where they are going — predictors of health,” Marks said.

Some of the results are eye-opening. The healthiest of Illinois’s 102 counties is Kendall, which is located next to LaSalle County, which ranked 65th.  LaSalle County, whose smoking rate is twice the national average, is home to twice as many people who can be considered to be in fair to poor health.  The divide between suburban and rural also comes into play here.  Kendall County is close enough to Chicago be almost be considered part of the metropolitan area, while LaSalle County is rural and home to many farms.  According to Dr. Remington, “Affluent suburbs tend to have higher-paying jobs, often in the cities, whereas rural communities often are dealing with loss of business.”  Rural populations also are in decline as younger and healthier people move away from places like LaSalle County to the cities where employment opportunities are more varied.  To improve the health of its citizens, LaSalle County health department officials are giving nicotine patches to smokers and educating school officials about obesity and diabetes.

“It’s hard to lead a healthy life if you don’t live in a healthy community,” said Risa Lavizzo-Mourey, M.D., M.B.A., president and CEO of the Robert Wood Johnson Foundation.  “The County Health Rankings are an annual check-up for communities to know how healthy they are and where they can improve.  We hope that policymakers, businesses, educators, public health departments and community residents will use the Rankings to develop solutions to help people live healthier lives.”

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).

Senate Advances on Reshaping Healthcare Coverage

Tuesday, July 21st, 2009

A crucial Senate committee has approved legislation to reform the nation’s healthcare system.  This is significant because it marks the first time the committee has acted on legislation to fulfill President Obama’s goal of reshaping how healthcare is paid for in the United States.s-obamated-large

Specifically, the Health, Education, Labor and Pensions Committee voted 13 – 10 — along strict party lines — to endorse a $600 billion measure to expand coverage to virtually all Americans by requiring individuals to get insurance with their employers contributing to the cost.  If enacted into law, the legislation would provide federal aid to families and individuals who make less than four times the poverty level – approximately $88,000 for a family of four.

The committee’s chairman, Senator Ted Kennedy of Massachusetts, missed the vote because of his ongoing treatment for brain cancer.  Even though Senator Kennedy is acting behind the scenes in the push to pass this legislation, he remains one of the prime movers for enacting healthcare reform.