Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says that she wants to restore public confidence in the FDA, according to Boston.com.

She already has Senator Edward M. Kennedy’s support. “Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies,” Sen. Kennedy said in a statement for the Health, Education, Labor, and Pensions Committee hearing.

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The Obama administration has named two doctors to head up the much-criticized U.S. Food and Drug Administration (FDA), individuals who are known for speaking out about public safety. Sources say Margaret Hamburg, a physician and former New York City health commissioner, was selected to run the agency with Joshua Sharfstein, of the Baltimore health commission, as her chief deputy, according to The Washington Post.

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Lawmakers’ concern over the U.S. becoming too reliant on foreign countries to produce drugs are calling for a rule to require certain drugs to be made or stockpiled in the U.S., according to the New York Times. The Times quotes Sen. Sherrod Brown of Ohio as saying that relying on other countries to produce our country’s medicines opens the door to “supply disruptions, counterfeit medicines, even bio-terrorism.”

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A drug development company, Glycotek, is establishing a laboratory at the Hershey Center for Applied Research (HCAR) in Hummelstown, Penn., to focus on a long sought after oral alternative to heparin to treat deep vein thrombosis and other thrombotic conditions, as well as cancer, according to Business Wire.

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There has been yet another report of heparin being pulled off the market for fear it may harm people. This week, French drug maker Sanofi-Aventis recalled the remaining batches of its heparin medicine distributed before May 2008, Lovenox, based on a recommendation by French drug regulator Afssaps.

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Recently, we reported about the development of synthetic heparin as a safer alternative to today’s heparin, which is manufactured from the intestines of animals. The work is a project of Robert Linhardt, a professor at Rensselaer Polytechnic Institute in Troy, New York. Recently, Linhardt presented information about his work on the synthetic heparin, as well as findings in a new project using heparin to create a “paper battery,” at the NanoBioTech forum.

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This week APP Pharmaceuticals, headquartered in Schaumberg, Ill., announced it has gotten FDA approval to manufacture heparin at its Barceloneta, Puerto Rico, facility. The facility will manufacture three product codes of heparin sodium injection, USP.

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Robert Linhardt, a scientist at Troy, New York-based Rensselaer Polytechnic Institute, is leading a team of researchers who have developed a fully synthetic version of the blood thinner heparin. While the group has only produced a few milligrams of the substance, it is the first step in eliminating the risk of contamination currently associated with the drug, which is manufactured primarily from pig intestines.

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