Posts Tagged ‘Senator Bernie Sanders’

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.”

Medicare for All!

Thursday, June 2nd, 2011

As Vermont becomes the first state in the nation to enact single-payer healthcare coverage, Senator Bernie Sanders (I-VT) and Representative Jim McDermott (D-WA) have introduced legislation to make Medicare for all the law of the land. Called the American Health Security Act of 2011, Senator Sanders said the legislation is necessary because “The United States is the only major nation in the industrialized world that does not guarantee healthcare as right to its people.  Meanwhile, we spend about twice as much per capita on healthcare with worse results than others that spend far less.  It is time that we bring about a fundamental transformation of the American healthcare system.  It is time for us to end private, for-profit participation in delivering basic coverage.  It is time for the United States to provide a Medicare-for-all single-payer health coverage program.”

Sanders and McDermott have strong backing from Arlene Holt Baker, executive vice president of the AFL-CIO; Jean Ross, co-president of the National Nurses United; and Greg Junemann, president of the International Federation of Professional and Technical Engineers.  All three groups are encouraging this fight for real reform.  “Providing a single standard of high quality care for all is a priority for registered nurses who have seen their abilities to act as patient advocates made more difficult as for-profit interests control more patient care decisions,” said Ross, whose union has been in the forefront of the fight for single-payer. “We commend Senator Sanders and Representative McDermott for their vision and passion to help registered nurses create a more just healthcare system through the American Health Security Act and applaud our brother and sisters in labor for their support,”  Physicians for a National Health Program, which consists of doctors and medical students who want real reform, also are supporting the national legislation, which is unlikely to end up on President Obama’s desk for signature.

Writing in the British newspaper the Guardian,  Sanders says that “Under our dysfunctional system, 45,000 Americans a year die because they delay seeking care they cannot afford.  We spent 17.6 percent of our GDP on healthcare in 2009, which is projected to go up to 20 percent by 2020, yet we still rank 26th among major, developed nations on life expectancy, and 31st on infant mortality.  We must demand a better model of health coverage that emphasizes preventive and primary care for every single person without regard for their ability to pay.  It is certainly a step forward that the new health reform law is projected to cover 32 million additional Americans, out of the more than 50 million uninsured today.  Yet projections suggest that roughly 23 million will still be without insurance in 2019, while healthcare costs will continue to skyrocket.”

All Vermont residents will be eligible for coverage under the system, known as Green Mountain Care.” Originally promoted as a “single-payer plan,” the measure is referred to as a “universal and unified health system.”  Governor Peter Shumlin has said he will sign the bill into law.  “This really is an extraordinarily exciting moment for Vermont,” according to Shumlin.  “We have a long way to travel, but I am convinced we can get healthcare right and this is the bill that will get us there.”

Meanwhile in California, some legislators have revived a bill to create a single-payer healthcare system.  It would replace President Obama’s healthcare reform legislation with a more comprehensive system – one that would cost no more than what people already pay.  Opponents categorically deny that assertion.  One academic observer of healthcare policy said, “If you think the fight over affordable care was nasty, you haven’t seen anything yet.  This plan is going to gore a lot of oxen,” said Gerald F. Kominski, associate director for UCLA Center Health Policy Research.  “No.1 is the insurance industry. They are not about to see their business go up in smoke.”

California’s proposed plan establishes a single- payer “Medicare for All” type of program by pooling the money that government, employers, and individuals already pay and using that money more efficiently by cutting out the middle man – insurance companies.  “There are some 6,000 health plans in California, and health care providers spend about one-third of their resources just getting paid,” said State Senator Mark Leno of San Francisco.  There will be other saving opportunities as well – such as bulk purchasing power for everything from pharmaceuticals to hearing aids, eyeglasses and the investment in primary and preventive care.

When asked if he thought the legislation has a chance to become reality in California, Kominski said, “I’ve seen enough things happen to never say ‘never.’  I don’t know how the ongoing financial crises might change public opinion on healthcare to vote for a more fundamental change of healthcare delivery.”