Posts Tagged ‘Bipartisanship’

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.”

2012 Budget Has Funds to Reform Medical Liability Laws

Wednesday, March 2nd, 2011

In a move that builds on the healthcare reforms contained in the Patient Protection and Affordable Care Act – and one that will make physicians very happy — President Barack Obama’s fiscal 2012 budget includes $250 million in grants over the next three years to subsidize efforts to help the states overhaul their medical liability laws. If the budget passes, the grants will be administered by the Justice Department in consultation with the Department of Health and Human Services (HHS).  As much as $100 million will be disbursed in fiscal 2012, with $50 million in each of the succeeding three years.  According to the Justice Department’s budget outline, the grants will fuel reforms that “fairly compensate patients who are harmed by negligence, reduce providers’ insurance premiums, weed out frivolous lawsuits, improve the quality of healthcare, and reduce medical costs associated with defensive medicine.”  The grants build upon $25 million in grants HHS awarded last June through the Agency for HealthCare Research and Quality safety and medical liability demonstration projects by states and health systems.

“I think the president is very serious about following up on this,” HHS Secretary Kathleen Sebelius,  whose agency would advise the Justice Department on awarding the grants, told the Senate Finance Committee.  Specific reforms might exclude caps on jury awards that the American Medical Association and Republican lawmakers have wanted for years.  At the same time, they include measures unacceptable to trial lawyers, a group that contributes heavily to Democratic candidates.

Philip K. Howard, chairman of Common Good, described the budget item as “A very significant moment for controlling healthcare costs.” Based in New York, Common Good has taken the lead in supporting special courts in which judges with healthcare backgrounds would resolve medical liability cases.  “With this budget item, President Obama is moving beyond bipartisanship and, in effect, saying that the country can no longer afford the rising healthcare costs that defensive medicine unnecessarily fuels,” Howard said.  President Obama also called for tort reform legislation in his 2011 State of the Union address.

The cost of defensive medicine to American healthcare consumers is not easy to estimate. Conservative estimates place the cost at approximately $50 billion a year.  The Obama debt commission estimated that its recommendations could save government programs $17 billion through 2020, calling for an aggressive effort to rewrite malpractice laws.

Gibson Vance, president of the American Association for Justice, described the proposal as “bad policy and bad for patients.”  The president’s proposal also got a chilly reception from congressional Republicans, who contend that he has promised more on malpractice than he has been able to deliver.  Obama initially voiced an interest in the issue during the lengthy healthcare reform debate.  He has opposed another malpractice alternative: capping the amount a patient can receive in a medical liability case.  This alternative is favored by many physicians and Republicans, but opposed by the majority of Democrats.

“These grants will help states reform their laws to pursue innovative approaches that will improve the quality of healthcare, fairly compensate patients who are harmed by negligence, reduce medical costs and liability, and protect patient safety,” said Justice Department spokeswoman Tracy Schmaler.