Posts Tagged ‘Senator Tom Harkin’

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.”

Was the NY 26th District Upset A Turning Point in the Medicare Debate?

Monday, July 18th, 2011

Was Kathy Hochul’s upset victory in a special election in New York’s 26th Congressional district a game changer in attempts to eliminate Medicare for Americans currently under the age of 55?  Medicare proved to be the decisive issue in the New York election, giving the Democrats a crucial campaign theme for the 2012 presidential election.  The party slammed Republican nominee Jane Corwin for her support of Representative Paul Ryan’s (R-WI) controversial budget plan and its proposal to turn Medicare into a voucher-like system.  Corwin lost to Hochul (D-NY) by four points in a Republican-leaning district. 

Almost immediately after Hochul was declared the winner, Democrats issued statements crediting her win to opposition to the plan “to end Medicare.”  Polling appears to support the Democrats’ approach.  A CNN/Opinion Research Corporation poll determined that 58 percent of the public opposes the plan to change Medicare to a voucher program, while just 35 percent support it.  “Our message is simply: Take Medicare off the table,” Senator Tom Harkin (D-IA) said.

There is still disagreement across the aisle.  According to a senior Republican aide, “Everyone knows that the surest way to destroy Medicare is to pretend like it doesn’t need to be fixed, which is why nearly every Democrat that matters has made clear that Medicare is on the table.  But Democrats are in a tough spot.  And they’re trying to use Medicare to provide a temporary solution to a much larger political problem they’re facing.”  Republicans get “huffy” when you call Ryan’s Medicare plan a voucher scheme, according to the New York Times’ Paul Krugman, who points out that they are trying to replace Medicare with “an entirely different program — call it ‘Vouchercare’.  According to Krugman, it isn’t “demagoguery, it’s just pointing out the truth.”

Senate Democrats warned after Hochul’s victory that they’d take their Medicare message to the stump in other contentious races, and that is what they’re doing with locally focused ads targeting Nevada, Florida, Massachusetts, Missouri, Montana, New Mexico, Ohio, and Virginia.  The Democratic Senatorial Campaign Committee plans to “mobilize thousands of online activists,” through ads on Google, Facebook, and other websites, to “stand up for Medicare” by calling on their Republican senators to withdraw their support for changes to Medicare.

Writing in the Columbia Missourian, Joseph Sparks explains the dilemma that turning Medicare into a voucher problem can create for people caught in the middle. “Proponents of Representative Paul Ryan’s Medicare proposal have said that people older than 55 would not be affected by his proposal to change Medicare into a voucher system.  They forgot about the Medisplit Effect.  My wife and I represent the perfect paradigm for this effect.  I will be 55 before the end of the year, but my wife is younger.  So, while I will get Medicare, my wife, under Ryan’s plan, will get a voucher to buy private insurance, and it will cost my family an extra $6,400 to $7,000 per year after 2022.  This Medisplit Effect, depending on the age of someone’s spouse, could still drastically affect people 55 and older.  It is disingenuous for Ryan or anybody else to suggest otherwise.  After the initial $6,400 hit, the plan’s severe impact on the economic health of future seniors, such as my spouse, just gets worse.  Based on a report from the Congressional Budget Office, theCenter for Economic and Policy Research calculated that in 2022, Ryan’s proposal would require that seniors pay 35 percent of their projected median income for health insurance.  Since the proposal does not require the government to increase the subsidy enough to match inflation, the percentage of median income required per senior increases to 44 and 68 percent in 2030 and 2050, respectively.  Medicare would be ‘saved’ at the expense of seniors being unable to afford it.”

Taking an opposite viewpoint is the Washington Post’s Jennifer Rubin.  In her “Right Turn” column, Rubin says that “Mediscare isn’t working on everyone.  Republicans should take heart: There are non-conservatives who are persuadable by reason and specifics.  It would be best if they found someone entirely familiar with the facts, calm in his delivery and earnest in his approach to lead their party on this monumentally important issue.  Gosh, do we know anyone who fits that bill?”

Jonathan Chait, writing in The New Republic disagrees.  According to Chait:

“How are Republicans responding to the unpopularity of the Medicare plan in their budget?  Phase one is for anybody not already committed to the plan to slowly, slowly edge toward the door:  (Republican presidential candidate Tim) Pawlenty congratulated himself on Tuesday for speaking bold truths. ‘I promised to level with the American people,’ he said.  ‘To look them in the eye.  And tell them the truth.’  Here’s a truth: The biggest fiscal threat to the country is the exploding growth of healthcare costs, especially through Medicare.  Pawlenty’s speech did not mention the word ‘Medicare’ a single time.  It will be interesting to see if Republicans let this stand.  Pawlenty’s plan involves staggeringly high tax cuts — will that be enough to get him off the hook for leaving healthcare untouched?  Phase two is for everybody already committed to Vouchercare to try to get to the left of the Democrats.”

Lame-Duck Senate Approves Food-Safety Legislation

Wednesday, December 8th, 2010

The Senate recently passed landmark legislation to make food safer and prevent deadly outbreaks of E. coli and salmonella.   The law – if the House of Representatives also gives its blessing – gives the federal government broad powers to step up inspections of food processing facilities and compel firms to recall bad food.  The $1.4 billion legislation – which will impose stricter standards on imported foods – sailed through the Senate on a bipartisan 73 – 25 vote.  Outbreaks of food-related diseases have strained the Food and Drug Administration’s (FDA) resources in its efforts to trace the contaminated products and take them off the market.

The legislation emphasizes prevention so the FDA can halt outbreaks before they start.  Farmers and food processors will be required to tell the FDA how they are working to keep food safe throughout every stage of production.  President Barack Obama hailed the bill’s passage, noting that “We are one step closer to having critically important new tools to protect our nation’s food supply and keep consumers safe.”  Despite broad support, the bill had stalled in the Senate because some feared it would harm small-scale farmers.  Senator Jon Tester (R-MT) added an amendment that will exempt some of those operations from expensive food safety plans required by bigger producers.

Although the House of Representatives approved the legislation in July of 2009, that bill does not include the same exemption.  With little time left in the current lame-duck session of Congress, the question is whether the Senate and House can reconcile the two versions of the bill.  Senator Tom Harkin (D-IA), a sponsor of the legislation, said there is support in the House to pass the Senate version of the bill.  If Senator Harkin is correct, the bill could be on its way to the White House for President Obama’s signature before the 111th Congress goes into recess.