by Rachel Stockton

Created on: March 03, 2009

The United States Food and Drug Adminisration was established in 1906, and is in charge of approving new drugs and the requisite clinical trials of those medications, as well as the oversight of food and drug manufacturing. Following is a mere smattering of what is currently on the FDA's regulatory agenda for 2009.

Restrictions for Schedule II Opiates

In February 2009, the FDA made the announcement that they sent information out to manufacturers of certain Schedule II narcotics to let them know that they will need to come up with "Risk Evaluation and Possible Mitigation Strategies", or REMS, in an effort to curb abuses that have come about through doctors prescribing poorly, or those failing to recognize and explain the risks to patients. Over the last decade, death and severe injury have been the result of misuse and abuse of certain extended release opiates, such as Fentanyl, Oxycodone (Oxycontine Extended Release) and Duragesic. The drugs (24 in all) targeted are all extended release medications, which were supposed to curtail some of the risk associated with opiates.

However, drug abusers have found ways to circumvent the extended release feature of the medications by crushing them and/or injecting them through the nostrils or intravenously. The purpose of the new REMS programs is that only certain doctors who have been educated about the risks of such drugs will be allowed to prescribe them. A complete list of the drugs can be found at www.fda.gov/cder.

Stem Cell Trial

In January of 2009, the FDA issued its approval for a trial involving stem cell injections into the victims of severe spinal cord injury, to stimulate cell regeneration. While denying that the timing of the announcement is mere coincidence, many insiders believe that it's no mistake that the declaration coincided with President Obama's inauguration. Some concur that it's also in response to the ousting of the Bush Administration, who has long opposed stem cell research, because of its dependence on the destruction of human embryos.

In the approved trial, the embryonic stem cells would be injected in accident victims 7-14 days after injury. Stem cells have long been touted as the key to regenerative medicine, as they can regenerate in any organ of the human body.

Farming and Pharmaceuticals

The FDA has approved, for the first time, a drug produced by bioengineered livestock. The anti-clotting protein, called antithrombin, is sometimes in short supply because of a lack of human donors. Antithrombin is now produced in the milk of 200 bioengineered goats that live on a farm in Massachusetts.

Proponents of the "pharm" animals contend that bioengineered livestock can provide a more cost effective method of producing certain biotech drugs. While the Humane Society of America has issued a statement opposing the use of animals for this type of research, the proponents of this type of technology are pleased that they've made it over the first hurdle of regulatory agency approval.

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