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Healthcare news roundup: FDA responds to shortage of nutrition drugs for infants

May 30, 2013 09:31 AM

The week in healthcare news brings word that the Food and Drug Administration (FDA) has approved the import of certain drugs for premature babies in response to a critical shortage and lawmakers calling for increase scrutiny of Ranbaxy Laboratories.

FDA addresses nutrition drug shortage 

On May 29, federal health officials announced that they will help make new supplies of drugs used to nourish premature infants available to patients after a shortage at hospital across the U.S.

The FDA said it would temporarily allow imports of trace drug ingredients, including potassium phosphate, to be shipped to the U.S. from a plant in Norway to alleviate the shortage caused by the shutdown of Regent's manufacturing plant in New Jersey due to contamination issues.

The injectable drug, which is a hospital staple, is used to feed newborn babies, cancer patients and others who can not eat or drink by mouth.

"If they cannot eat anything by mouth they have to be provided intravenous nutrition or they'll starve to death in a very short period of time," Jay Mirtallo, professor of clinical pharmacy at Ohio State University, told CBS News,. While the formula is most critical for infants, he said that "we have patients from 2 years old to 90 years old who are on it."

Congress calls for improved oversight of foreign plants

In an effort to improve oversight policies in the pharmaceutical sales industry, New York Congressman Steve Israel has sent a letter to the Department of Health and Human Services calling for a complete review of the FDA's investigation into fraud at Ranbaxy Labs.

The Economic Times reports that Israel is also calling for a review of the FDA's oversight policies when it comes to potential fraud at all foreign manufacturing facilities. Earlier this month, Ranbaxy officials pleaded guilty to seven counts of federal criminal and civil charges following an eight-year investigation.

"It is simply unacceptable that we should have to question whether a pharmaceutical drug or an active ingredient is safe or effective because it is produced overseas," Israel wrote.

Israel said that despite the fact that the FDA has stepped up its inspections of factories overseas, the quality of those reviews is questionable since companies are given weeks of advanced notice.

IRS issues new guidelines on medical device tax

The Internal Revenue Service (IRS) has issued new guidelines to help medical device manufacturers determine which products could be exempt from the 2.3 federal excise tax recently imposed on the healthcare industry to help pay for the Affordable Care Act.

CFO Magazine reports the new guidelines could help those with medical device sales jobs since they will show that a number of products, including those sold over the internet or telephone, will be exempt from the tariff, which will in turn help ease costs. The IRS has also more clearly defined the supply chain, including wholesalers and distributors.

"There's been a lot of confusion about that when people in the industry think they are selling to wholesalers, but really the excise tax world would consider that person a retailer under these definitions that are provided for in the regulations," Deborah Gordon, senior manager in the excise tax practice at KPMG's Washington National Tax group, said.

Gordon said that manufacturers still face challenges under the new tax, including how to determine the estimated price of a device before an actual sale has occurred.

FDA approves two new skin cancer treatments/companion test

In a move that could help generate more medical sales jobs, the FDA announced on May 29 that it had approved two new skin cancer treatments from GlaxoSmithKline, 

The agency that it approved both Tafiniar and Mekinist as separate therapies for patients with advanced melanoma, which is the most dangerous type of skin cancer. The National Cancer Institute reports that approximately 76,690 Americans will be diagnosed with the disease this year. 


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