Posts Tagged ‘Food and Drug Administration’

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.”

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.

FDA to Put Gruesome Warning Labels on Cigarette Packs

Tuesday, November 23rd, 2010

FDA is ramping up its anti-smoking efforts with extremely graphic new warning labels.  The Food and Drug Administration (FDA) has concluded that years of warnings about the dangers of smoking cigarettes, the availability of nicotine patches and gum has not worked.  Instead, the FDA is proposing to put gruesome images on cigarette packs that warn of the consequences of smoking.  Tobacco is the leading cause of early and preventable deaths in the United States, accounting for 433,000 annual deaths and approximately 33 percent of all cancer deaths.  The healthcare reform law provides free access to anti-smoking therapies; the stimulus bill included $225 million to support local, state and national anti-smoking programs.

The proposed images, which include one of a man suffering a heart attack and another of a mother blowing smoke in her baby’s face, would cover half the front and back of each pack if adopted.  “When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes,” said Margaret A. Hamburg, FDA Commissioner.  The FDA plans to choose nine images by June 22.  After October 22, 2012, cigarette manufacturers who refuse to put the new warnings on their product will be banned from selling their brands in the United States.  Anti-tobacco activists applauded the move.  “In implementing the new warnings, the United States is catching up to scientific best practices,” said Matthew Myers of the Campaign for Tobacco-Free Kids.

Not surprisingly, some tobacco companies are not thrilled.  R. J. Reynolds Tobacco Company, which is already suing the government over tobacco regulations, is reviewing the proposed warnings.  “It is worth noting that the legality of requiring larger and graphic warnings is part of our lawsuit that is currently pending,” said company spokesman David Howard.  Philip Morris USA, on the other hand, has been supportive of FDA regulations; the company “has actively participated in the FDA’s rule-making and public comment process and plans to do the same on this proposal.”

Canada, which has used graphic warnings since 2000, has seen a significant reduction in smoking.  “It’s always difficult to point to a particular policy and say it’s due to that,” said David Hammond, a researcher of the University of Waterloo in Ontario.  In fact, smoking rates in Canada have fallen approximately 20 percent since 1985.  “But all the evidence does point to the fact that these things do help.  The bottom line is that there’s no magic bullet.  But about one-third of smokers say this increases their motivation to quit, and about the same proportion of former smokers say they remind them why they quit.”

FDA Takes a Proactive Approach to Improving its Oversight

Wednesday, October 20th, 2010

FDA to spend $25 million to upgrade their review processes.  The Food and Drug Administration (FDA) is upgrading the scientific tools they use to review prescription drugs, medical devices and to oversee food safety. According to FDA Commissioner Margaret Hamburg, her agency will spend $25 million next year to collect suggestions from scientists in academia, government and industry with the goal of approving new products faster and enhancing troubleshooting.  “Regulatory science can deliver better, more targeted therapies more quickly,” she said.

The FDA wants to pool resources on a variety of projects, including predicting the side effects of pharmaceuticals based on patients’ genetic codes; reduce or eliminate drug testing on animals; and prevent salmonella and other bacteria in the food supply.  Modernization is a constant theme at the FDA and the agency is working to keep up with the ever-evolving science behind the newest drugs, medical devices and even foods.  Unfortunately, federal funding at the FDA typically has not kept up with requests for budget increases.  This has resulted in user-fee programs where pharmaceutical manufacturers and medical device manufacturers pay to have their products reviewed.

Healthcare Reform Emphasizes Prevention

Monday, May 3rd, 2010

Little-known provisions of healthcare reform bill encourage prevention and healthier lifestyles.  Lost in the war of words about healthcare reform is a series of initiatives intended to prevent disease and promote healthier behavior.  Under the new law, for example, chain restaurants will be required to provide nutrition information on their menus; nursing mothers must be given “reasonable break time” by their employers.

Americans on Medicare will be given free yearly “wellness” physicals to assess their overall condition and screen for symptoms of Alzheimer’s Disease.  Medicaid will cover drugs and counseling to help pregnant women stop smoking.  Additionally, a new federal trust fund will pay for bicycle paths, playgrounds, sidewalks and hiking trails to encourage exercise.  These are just a few of the many provisions Congress added to the healthcare reform bill to reduce preventable diseases – and which ultimately could save the government money.

According to John R. Sefrin, chief executive of the American Cancer Society, the new law will save lives because more people will be screened for diseases like breast and colon cancer.  “When people have insurance, they are much more likely to receive screenings and treatment.  And they are more likely to seek screenings when they do not have to pay co-payments or deductibles.”  These screenings mean that diseases like cancer might be detected earlier when they are more easily treatable.

Senator Tom Harkin (D-IA) and chairman of the Senate health committee, points out that “we don’t have a healthcare system in America.  We have a sick care system.  If you get sick, you get care.  But precious little is spent to keep people healthy in the first place.”

Consumer Advertising Could Be Behind Spike in Prescription Drug Prices

Monday, December 7th, 2009

Prescription drug prices have risen 9.3 percent since October of 2008, according to a finding by the AARP Rx Watchdog Report.  In remarks on the price increase, AARP Executive Vice President John Rother said, “This report confirms what most older Americans already know:  drug makers are raising their prices and enjoying windfall profits, even as the rest of the economy is suffering.  The pharmaceutical industry should be embarrassed when it sees its own price increases put side-by-side with the general inflation rate.  Even as the cost of most goods and services drops, a person taking just one brand name drug now pays $200 more per year than a year ago.”

Another study found that consumer advertising might boost the price of prescription drugs.  A case in point is the blood-thinning drug Plavix, which is heavily advertised on television.  An article in the Archives of Internal Medicine, written by Dr. Michael R. Law of the University of British Columbia in Vancouver, found that Medicaid costs for Plavix rose after manufacturer Bristol Myers Squibb/Sanofi-Aventis began advertising the drug to consumers in 2001.  After the ad campaign started, Plavix cost 40 cents more per pill, a 12 percent increase that added $207 million to Medicaid spending on prescription medicines.

Earlier research conducted by Dr. Law found that advertising didn’t result in an increase in people taking the medication.  “The public should rightly wonder why they’re paying millions in extra drug costs to pay for advertising campaigns that don’t work,” Dr. Law said.  In response, Plavix’s manufacturer notes that “The Bristol Myers Squibb/Sanofi pharmaceutical partnership support direct-to-consumer advertising as a way to encourage consumers to play a more active role in their healthcare.”