Secretary Sebelius Releases $7.6 Million in Recovery Act Funds to Support Health Professionals Serving in High Need Areas

The grant awarded to Georgia under this announcement was to State Medical Education Board of Georgia.

HHS Secretary Kathleen Sebelius yesterday announced 63 awards totaling more than $7.6 million to help states recruit new health care clinicians and alleviate their debt burden. The funds are part of the $500 million appropriated to HHS’ Health Resources and Services Administration (HRSA) by the American Recovery and Reinvestment Act (ARRA) to address workforce shortages and encourage diversity in the health professions.

“These funds will help place full-time primary care health professionals in shortage areas and help hundreds of thousands of Americans get primary care they might not otherwise receive,” said Secretary Sebelius.

Eighteen grantees will receive $5.8 million under the State Loan Repayment Program, which provides grants to states to fund loan repayment programs designed to increase the availability of primary health service providers in health professional shortage areas in the state. Health professionals receiving these funds incur a minimum two-year service obligation, but in some cases elect to serve longer. In return for their service in shortage areas, the state repays their qualifying loans. States must provide a dollar-for-dollar match in funding.

In addition, 45 grantees will receive $1.8 million under the State Primary Care Office program to help recruit new National Health Service Corps (NHSC) clinicians. On June 5, Secretary Sebelius announced the availability of $200 million in ARRA workforce funds, of a total $300 million, to expand HRSA’s National Health Service Corps, which provides scholarships and loan repayment for primary care providers who serve in health professional shortage areas. The funds will repay the qualifying student loans of primary care medical dental and mental health clinicians who wish to practice, for a minimum of two years, in NHSC sites that treat underserved and uninsured people.

“Recruiting and training health professionals to serve in shortage areas is critical as we work to provide quality health care to more and more people in need,” said HRSA Administrator Mary Wakefield, Ph.D., R.N.

Yesterday’s awards follow a Sept. 11 announcement by Secretary Sebelius of $33 million in Recovery Act funds to train a variety of health professionals. Also, on Aug. 12, HHS Deputy Secretary Bill Corr announced awards of $13.4 million in Recovery Act funds for loan repayments to nurses who agree to practice in facilities with critical shortages and for schools of nursing to provide loans to students who will become nurse faculty.

HRSA also received $2 billion through the ARRA to expand health care services to low-income and uninsured individuals through its health center program. To date, more than $1.4 billion of these funds have been awarded to community-based organizations across the country. HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance.

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Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply

The U.S. Food and Drug Administration today approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, N.C. and Philadelphia.

A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, N.J.).

This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from Dec. 18, 2007, through June 25, 2009.

Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.

“The FDA approved Hiberix under the agency’s accelerated approval pathway,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations.”

Before the availability of Hib vaccines, Hib disease was the leading cause of bacterial meningitis among children under 5 years old in the United States. Meningitis is an infection of the tissue covering the brain and spinal cord, which can lead to lasting brain damage and deafness. Hib disease can also cause pneumonia, severe swelling in the throat, infections of the blood, joints, bones, and tissue covering of the heart, as well as death. Hib disease is spread through the air by coughing and sneezing.

In 1992, the FDA disseminated rules regarding accelerated approval. The rules allow for earlier approval of treatments that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (including products that provide prophylaxis to those who would not otherwise be treated during a shortage). The use of such an approach can shorten the time required for product testing prior to receiving FDA approval. Accelerated approval is granted on the condition that clinical trials are continued during the post-approval marketing of the product to verify the anticipated clinical benefit.

Hiberix is used in nearly 100 countries. The FDA based its conclusion that Hiberix is safe and effective for use as a booster dose in certain children in the United States on data from seven clinical studies conducted in Europe, Latin America and Canada that involved more than 1,000 children.

As part of the approval, the manufacturer, GlaxoSmithKline, will conduct a post-market study in the United States to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the United States. The study is intended to confirm the clinical benefit of booster immunization with Hiberix in accordance with the accelerated approval regulations, and to provide additional data on Hiberix for young infants.

The most common side effects seen in the studies following a booster dose of Hiberix included pain and redness at the injection site, fever, fussiness, loss of appetite and restlessness.

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FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid

The U.S Food and Drug Administration has amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

The FDA took this action in response to concerns from patients and health care professionals in the palliative care community that the action taken on March 30 would cause a shortage of 20 mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients. The agency has determined that this dosage form is medically necessary, and should remain on the market until an approved alternative becomes available to the patients that need it.

“While the FDA remains committed to ultimately ensuring that all prescription drugs on the market are FDA approved, we have to balance that goal with flexibility and compassion for patients who have few alternatives for the alleviation of their pain,” said Douglas Throckmorton, M.D., deputy director, FDA’s Center for Drug Evaluation and Research. "In light of the concerns raised by these patients and their healthcare providers, we have adjusted our actions with regard to these particular products."

To address the needs of palliative care patients, the FDA will allow companies that are currently manufacturing and distributing versions of this unapproved prescription product to continue to do so on an interim basis until an FDA-approved version of this product or another acceptable alternative therapy becomes available for this patient population.

“The FDA appreciates the help we received from the palliative care community about how this drug is being used today to help patients,” said Theresa Toigo, director, FDA’s Office of Special Health Issues. “We want to continue to talk to them as we move forward on this difficult issue.”

Today’s decision only affects the high concentrate morphine sulfate solution. Companies that received warning letters from the FDA on March 30 concerning other unapproved prescription opioid products will still be required to cease production and distribution of those products within the timeframes set out in those letters. The other products affected by the enforcement action are: immediate release tablets containing morphine sulfate, hydromorphone, and oxycodone.

The March 30 action is part of the FDA’s Unapproved Drugs Initiative, which seeks to ensure that all drugs available on the U.S. market have met FDA’s standards for safety, efficacy, and quality.

For more information about this action: http://www.fda.gov/cder/drug/unapproved_drugs/morphine_extension.htm .

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