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Manufacturers, Market Have Role in Drug Shortages, Sebelius Says

Manufacturers, market have role in drug shortages, Sebelius says [The Philadelphia Inquirer]

From Philadelphia Inquirer (PA) (February 17, 2012)

Feb. 17--Health and Human Services Secretary Kathleen Sebelius said Thursday in Philadelphia that the federal government is doing all it can legally to alleviate drug shortages, but that manufacturers and market forces play the biggest role.

"Right now, there is a gap between demand and manufacturing capacity, which we cannot fix," Sebelius said after leading a panel discussion at the African American Museum that focused on health insurance access for women. "It really is market demand, and, frankly, drug companies are making decisions each and every day about which lines of drugs to run."

Sebelius said President Obama's recent order helped spur more companies to notify the Food and Drug Administration, an agency within her department, when they see a manufacturing problem that might cause a shortage. The FDA then looks for other manufacturers that might be able to help, but it cannot require notice, much less order production by a private company.

Doctors and patients, hospitals and pharmacists, manufacturers and wholesalers have argued for months about who is most responsible for shortages of certain medicines.

Many shortages involve injectable drugs used in hospitals for relatively few patients. Perhaps the most widely used medicines in short supply recently are some used to treat attention-deficit/hyperactivity disorder. For any patient, or parent, the overall number of those affected does not matter.

Shareholders, however, expect manufacturers to make a profit. If the drug is for a small patient population and payers -- usually public or private insurers -- will not pay enough, companies assess how much to manufacture. Factory shutdowns for repairs, or because the FDA found the need for maintenance, are another factor.

Teva Pharmaceuticals' Americas chief Bill Marth told Wall Street analysts Wednesday that Teva was working hard to help the shortage problem where it could, but that consumers and insurers do not appreciate the difficulty and cost of making sterile injectable drugs.

"Your attentiveness to detail, your quality, your system is so very, very important," Marth said. "I think at the price points we've seen in the United States, I don't think that this kind of pressure can continue. We're going to have to get more for our product. I've said time and time again that the days, from Teva's perspective, of supplying injectables for a buck a vial are gone."

Thursday afternoon, Sebelius also discussed the challenges of some women, especially African American women, in getting access to affordable health insurance. She noted the new health law helped.

"Now that the Affordable Care Act has passed, being a woman is no longer a preexisting condition," she said.

Earlier, Sebelius spoke at the first in a series of White House conferences planned around the country on issues affecting lesbian, gay, bisexual, and transgender Americans. About 350 medical professionals, advocates, and others from 22 states heard about administration efforts on issues such as preventing discrimination and improving research on LGBT health outcomes.

Contact staff writer David Sell at 215-854-4506 or Read his blog at and @phillypharma on Twitter.

Staff writer Don Sapatkin contributed to this article.


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Posted: February 2012