Anti-addiction groups call for new FDA chief

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Anti-addiction groups call for new FDA chief
FILE - This May 30, 2014, file photo shows Food and Drug Administration Commissioner Dr. Margaret Hamburg in Washington. Food companies and restaurants could soon face government pressure to make their foods less salty _ a long-awaited federal effort to try and prevent thousands of deaths each year from heart disease and stroke. The FDA is preparing to issue voluntary guidelines asking the food industry to lower sodium levels, Hamburg told The Associated Press. (AP Photo/J. David Ake, File)
IMAGE DISTRIBUTED FOR FDA YOUTH TOBACCO PREVENTION CAMPAIGN - Dr. Margaret Hamburg, Commissioner of Food and Drugs, speaks at a news conference announcing the FDA Youth Tobacco Prevention Campaign at the National Press Club on Tuesday, Feb. 4, 2014, in Washington. The new campaign, "The Real Cost," launches nationally Feb. 11th and uses a multimedia approach to reach teens, 12-17. (Kevin Wolf/AP Images for FDA Youth Tobacco Prevention Campaign)
In this photo provided by the Georgia Ports Authority, Food and Drug Administration Commissioner Dr. Margaret Hamburg, left, and Georgia Ports Authority Board Chairman Alex Poitevint, right, tour the GPA Garden City Terminal along with and U.S. Congressman Jack Kingston, R-Ga., center, Monday, April 9, 2012, in Savannah, Ga. (AP Photo/Georgia Ports Authority, Stephen Morton)
WASHINGTON - MAY 07: Dr. Margaret Hamburg (R) listens as Sen. Richard Lugar (R-IN) introduces her prior to testifying before the Senate Health, Education, Labor and Pensions Committee on Capitol Hill May 7, 2009 in Washington, DC. Hamburg testified on her pending nomination to become the next commissioner of the Food and Drug Administration. (Photo by Win McNamee/Getty Images)
US Food and Drug Administration Commissioner Margaret Hamburg speaks at a press conference following the signing of an APEC/World Bank Memorandum of Understanding regarding Food Safety, at the Asian Pacific Economic Cooperation (APEC) Ministerial Meeting in Big Sky, Montana May 18, 2011. From left to right are APEC Food Safety Cooperation Forum Co-Chairmen Dr Lin Wei from China and Steve McCutcheon from New Zealand, Inger Anderson, World Bank vice president for Sustainable Development Network, Hamburg, Pam Bailey, CEO of the US Grocery Manufacturers Association and Deputy US Trade Representative Demetrios Marantis. Trade representatives from the 21-member APEC forum are gathered in Big Sky, Montana to help lay out an agenda for a wide-ranging trade pact. The meeting is one of a series leading up to an APEC summit in Hawaii in November. AFP PHOTO / ROBYN BECK (Photo credit should read ROBYN BECK/AFP/Getty Images)
HOLLYWOOD - JANUARY 10: (L to R) Producer Christopher Koch, Nuclear Threat Initiative's VP of Biological Programs Dr. Margaret Hamburg, United States Air Force General Eugene Habiger and Leroy Richmond, the United States Postal Service veteran who contracted inhalation anthrax from tainted letters in the fall of 2001, participate in a panel discussion at the Renaissance Hotel concerning the film 'Avoiding Armageddon' on January 10, 2003 in Hollywood, California. The series, sponsored by PBS, takes an unflinching global look at the proliferation of nuclear, chemical and biological weapons. (Photo by Frederick M. Brown/Getty Images)
WASHINGTON - MAY 07: Dr. Margaret Hamburg arrives prior to testifying before the Senate Health, Education, Labor and Pensions Committee on Capitol Hill May 7, 2009 in Washington, DC. Hamburg testified on her pending nomination to become the next commissioner of the Food and Drug Administration. (Photo by Win McNamee/Getty Images)
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BY MATTHEW PERRONE

WASHINGTON (AP) - Anti-addiction activists are calling for the Food and Drug Administration's top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.

In a letter released Wednesday, more than a dozen groups ask the Obama administration's top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

The new letter is the first formal call for new leadership at the FDA over the issue.

"We are especially frustrated by the FDA's continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths," states the letter, which is addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies. The groups signing the letter include Physicians for Responsible Opioid Prescribing, a 900-member advocacy group that petitioned the FDA to drastically restrict opioid use. The FDA rejected that petition last year.

A spokeswoman for the Department of Health and Human Services said opioid abuse "is a serious issue and one that the secretary is focused on."

"Secretary Burwell appreciates hearing from stakeholders on the important issue of prescription opioid abuse, and looks forward to responding to their letter," said spokeswoman Tait Sye, in a statement.

Deaths linked to the addictive medications, including OxyContin and Vicodin, have more than tripled over the last 20 years to an estimated 17,000 in 2011, the most recent year for which the Centers for Disease Control and Prevention reports figures.

The CDC has called on doctors to limit their use of the medications to the most serious cases of pain, such as cancer patients and end-of-life care. But the vast majority of prescriptions written in the U.S. are for more common ailments like arthritis and back pain.

Hamburg has supported broad use of the drugs, noting that 100 million Americans reportedly suffer from chronic pain.

The letter to HHS says the commissioner and the FDA are out of step with efforts by the CDC and other parts of the federal government.

"Dr. Hamburg's support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice," states the letter, which is signed by the National Coalition Against Prescription Drug Abuse and 15 other groups.

FDA spokeswoman Erica Jefferson said Hamburg has been "a tireless public health advocate" for over 20 years.

"Preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA," Jefferson said in a statement.

The calls for Hamburg's resignation come almost a year after the FDA approved Zohydro, the first extended-release, pure form of hydrocodone ever cleared for the U.S. market. Hydrocodone was previously only available in immediate release, combination pills that contain smaller amounts of the drug.

Commissioner Hamburg has defended the drug's approval by saying that it fills an important medical niche. Older combination pills like Vicodin mix hydrocodone with other drugs like acetaminophen, which can cause liver damage at high levels.

Members of Congress from West Virginia, Massachusetts and Kentucky have introduced bills to ban the drug. And attorneys general from 28 states asked the FDA to revoke the drug's approval or require that the pills be reformulated to prevent users from crushing them for snorting or injection.

But Wednesday's letter also criticizes the FDA for approving drugs that are actually designed to be harder to abuse.

The groups take issue with the agency's July approval of a new painkiller called Targiniq, which combines oxycodone with the ingredient naloxone. The addition of naloxone is designed to block the euphoric effects of oxycodone when it is snorted or injected. But the groups point out that Targiniq tablets can still be abused by simply chewing them - the most common approach to abusing painkillers.

The FDA has faced criticism from lawmakers representing states that have been hardest hit by opioid abuse, including Sen. Joe Manchin of West Virginia, Sen. Charles Schumer of New York and Congressman Hal Rogers of Kentucky.

Media representatives for all three lawmakers declined to comment on the letter. The American Pain Society, which represents physician pain specialists, also declined to comment for this story.


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