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Drug Industry Backs FDA Split

Mar 23, 2009 | Parker Waichman LLP
FDA Reform Drug Industry

President Obama Repair A Broken FDA

As President Barack Obama takes steps to repair a broken U.S. Food and Drug Administration (FDA), the drug industry is hoping for an FDA split.  The Associated Press (AP) is breaking with the news that, amid continuing and newly emerging food borne illness outbreaks, tainted medications sickening consumers, and problematic medical devices being implanted into patients, Big Pharma actually wants separate regulation.

Industry is hoping, said the AP, that if the FDA is split into two separate agencies—one for medicine and medical devices and one for food—that drugs could actually receive expedited approvals.  And, while no industry officials are publicly announcing agreement with the formation of two agencies, privately, it seems Pharma is allying itself with the move.  "Every CEO that I know in healthcare is in favor of this, but none that value their share prices will go on the record for fear of retribution from the FDA," said Steve Brozak, president of WBB Securities, quoted the AP, which noted that WBB is an investment brokerage specializing in drug and biotech companies.

Obama Appointed A Group For Food Safety Laws

The AP said that, in his weekly radio address, President Obama announced two health specialists for the FDA’s two key positions; Obama also appointed a new group to look at the U.S.’s antiquated food safety laws.  President Obama's weekly address concentrated on food safety and the recent “troubling trend” of contaminated produce, reported Medical Marketing and Media, saying that Obama was concerned not just as the president, but also as a parent.  President Obama cited laws concerning food safety that have not been updated since Theodore Roosevelt was president, said Medical Marketing and Media.

Industry feels that with separate agencies, said the AP, drug approvals will not be caught up in lags that take a back seat to food safety catastrophes.  The debacles—including the recent problems with tainted peanut products, contaminated produce, and melamine-spiked milk from China—have caused, many argue, the FDA’s focus to shift to concerns about food safety, not new medicines, said the AP.  This, despite the fact that the FDA does have separate areas for food and drugs and devices, noted the AP.

Dr. Margaret Hamburg, a biodefense expert and former New York City health commissioner, will be appointed by the president to serve as FDA commissioner, said Medical Marketing and Media; Baltimore health commissioner Dr. Joshua Sharfstein will be appointed as principal deputy commissioner.  “As Baltimore's health commissioner, Dr. Sharfstein has been recognized as a national leader for his efforts to protect children from unsafe over-the-counter cough and cold medications,” Obama said, “and he's designed an award-winning program to ensure that Americans with disabilities had access to prescription drugs,” quoted Medical Marketing and Media.

Some say the two appointments are lending themselves to the formation of two agencies with Dr. Hamburg in charge of food safety and Dr. Sharfstein heading drug safety, said Medical Marketing and Media.  Of note, explained the paper, Representative Rosa DeLauro (Democrat-Connecticut) recently introduced legislation for the creation of a separate Food Safety Administration, which many see as one of the early steps to a split agency.

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