Obama Issues Executive Order To Ease Drug Shortages

PHOTO: President Barack Obama gestures in the Oval Office at the White House in Washington, Oct. 31, 2011, where he signed an executive order directing the Food and Drug Administration to take steps to reduce drug shortages.
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While many advocates say President Obama's executive order to reduce a dire shortage of life-saving hospital medications is an essential step, others say the order is not enough to stop price gouging by some pharmaceutical companies.

Essential cancer drugs have arguably taken the hardest hit. Hospitals have reported the worst shortage in nearly a decade of chemotherapy agents like doxorubicin. Drugs for heart patients, some antibiotics, and intravenous drugs have also been hard for hospitals to find.

The new order instructs the Food and Drug Administration to broaden reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages, and examine whether potential shortages have led to price gouging. The drug shortage has compromised or delayed care for some patients and may have led to otherwise preventable deaths.

Christopher W. Hansen, president of the American Cancer Society's Cancer Action Network, applauded today's order, saying in a statement that it would "allow government, industry, providers and the public to more systematically analyze and understand the causes of specific drug shortages as they occur, and to develop real-time solutions that are also needed to address the acute problems that cancer patients live with daily."

Limited manufacturing, lagging production time, and lack of profits from these drugs contribute to the shortages. The production costs for some drugs can outweigh the money that companies can make from them, since many drugs now have cheaper generic alternatives. So manufacturers stop making the drugs.

"The Executive Order allows us to really reinforce our critical activities and extend a very clear message from the Administration of the priority we're giving it," FDA commissioner Peggy Hamburg said at a press conference before the president's signing.

But while the FDA can oversee imports of drugs that are in short supply, it cannot regulate how much a company can make. In fact, manufacturers are not required to report shortages to the FDA.

The amount of a drug made available within a hospital is set by an agreement between the hospital and the manufacturer.

The executive order does not grant new authority to the Department of Health and Human Services or the FDA. Rather, it "advances" and "enhances" the FDA's oversight on a growing shortage of important chemotherapy drugs, anesthetics and antibiotics, Secretary of Health Kathleen Sebelius said.

Some pharmaceutical vendors have responded to the shortage by stockpiling vital drugs and offering to sell them to hospitals and clinics at inflated prices.

"Sometimes we run out of or run low on certain types of drugs, and that drives up prices and it increases patient risk," President Obama said today at the signing in the Oval Office.

The executive order calls on the FDA to work with manufacturers to notify the agency about manufacturing problems or if a drug will be discontinued.

But Dr. Sidney Wolfe of the public watchdog group Public Citizen said these new orders may be difficult to implement since manufacturing companies have little incentive to do so.

Wolfe said price gouging may continue "unless there are large financial penalties for companies failing to report anticipated shortages to the FDA."

The FDA has prevented 137 shortages in the last year and a half, but 178 drugs are still in short supply, Sebelius said.

"We can't wait," said Sebelius, echoing the president's repeated health care battle cry.

Under the new orders, the FDA will add six people to the five who are assigned to its drug shortage program. The agency will also add two staff members to its Center for Evaluation and Research.

"Obviously, this will put new additional pressures on the FDA in terms of personnel and time demands and financial demands," Hamburg said. "We will not be able to prevent all future shortages and fully remediate in the near term the existing shortages, but we can make a difference by expanding our net of early warnings and getting in there before the shortage occurs."

Twenty-one out of 23 medical centers surveyed by ABC News' Medical Unit say they still have significant drug shortage problems.

There are about 40,000 medications used in hospital settings on a regular basis, and fewer than 200 of those have been in short supply, said Sebelius.

While the number is relatively small, some types of drugs are first-line treatments that are essential to saving lives, she said.

According to Bonnie Frawley, a pharmacist at Brigham and Women's Hospital in Boston, doctors at the hospital were nearly one week away from canceling heart surgeries this summer because of a drug shortage.

The hospital had a shortage of a hard-hitting antibiotic called Gentamicin, which is the primary therapy used to for bacterial infections resistant to most other types of antibiotics, Frawley said.

"We were forced to use other antibiotics that were second-line therapy," Frawley said at the press conference. "This is a concern because health care providers may not have experience using alternatives."

Since these medications are mainly housed in hospitals, most patients won't know they can't have them until they really need them.

Maggie Heim, 58, of Hermosa Beach, Calif., was diagnosed with recurrent ovarian cancer in July 2011, and told by her doctors at Cedars Sinai Medical Center that she would have to wait to receive chemotherapy since the hospital had a shortage chemotherapy agent doxorubicin.

"I thought it was going to be available in two weeks, so I thought I'll just miss the first round of therapy," said Heim, who said she never knew about a shortage problem before her experience.

But more than three months later, the hospital has still not received enough doxorubicin.

"It was very disturbing to me to do research and see how many women with cancer are affected," said Heim, who is a member of the patient online community Inspire. "I was angry, but I was also disappointed that we as a country could not get our acts together."

Heim was offered an alternative drug that worked for her cancer, but she said many other women she has connected with after her experience need the drug to save their lives.

"How can our country do so much and so little?" she said.

ABC News' Mary Bruce contributed to this report

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