In addition, based on lobbying by certain drug companies, the FDA softened and even omitted some of the warning language on the risk of suicide in pediatric patients associated with some antidepressants. Bush even appointed David Hager, a physician with few credentials and a known penchant for trying to cure women's health issues with prayer and refusing to prescribe birth control to female patients, as head of the FDA's Reproductive Drugs Health Advisory Committee.

Food safety was also a concern, with a peanut-related salmonella outbreak that sickened hundreds and killed several people and few foods imported from overseas receiving inspection.

Corruption was so pervasive that when Obama took office in January 2009, FDA scientists wrote to him essentially begging for help in overhauling the failing agency. In April 2009, nine staff members at the FDA wrote him again, asking that some long-time top-level employees be fired--or even prosecuted.

The staffers are ecstatic about new leadership at the FDA but want bad managers who still remain on the job to be run out of the agency, and in some cases, prosecuted as criminals. The staffers, whose names are redacted, call for an end to "the culture of wrongdoing and coverup."

In President Obama's first budget, he allotted $1 billion to the FDA to "increase and improve inspections, domestic surveillance, laboratory capacity and domestic response to prevent and control foodborne illness."

President Obama's 2010 budget requests an additional 19 percent budget increase over last year, to $3.2 billion. The agency is in the midst of a three-year plan to raise the number of inspectors from 1,200 to 1,700 by 2010.

In February 2009, he also called for a full review of all departments at the FDA.

In March, he appointed two esteemed professionals--Margaret Hamburg and Joshua Sharfstein--as commissioner and principal deputy commisioner of the FDA and announced establishment of the Food Safety Working Group to meet regularly with cabinet officials and help advise the president on food safety issues and needs of the department.

These were clearly steps in the right direction. Since taking over, Hamburg's FDA has conducted several raids of manufacturers of items like soaps and food products, closing the companies down for poor sanitation and, in some cases, prosecuting owners. A maker of tuna salad sandwiches was closed after

Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions, and poor employee practices, such as allowing food-processing utensils to lie on the floor near live insects.

In June, the President signed a law giving FDA oversight of tobacco products, something many people felt was long overdue. This is expected to reduce smoking rates significantly in the long term, particularly by discouraging teen smoking through strict advertising laws. A judge recently upheld nearly all of the legislation's provisions in a lawsuit filed by tobacco manufacturers that sought to overturn sections of it.

The Center for Drug Evaluation & Research (CDER) is responsible for approving new drugs. After the Vioxx and other scandals, and possibly due to funding cuts, the process of approvals slowed significantly under the Bush administration. This drew complaints not only from pharmaceutical companies but from patient advocacy groups, who said many patients were being denied potentially lifesaving drugs due to the slow approval process.

As of December 1, 2009, the FDA had approved 26 new drugs, which is only 1 more than approved in 2008. However, they completed reviews of 85% of drug applications on time, which is a significant improvement. One reason for the improvement in meeting deadlines, even though the number of approvals remained nearly stagnant, was the increase in hiring:

Over the last two years, CDER has seen a 34 percent increase in the number of full-time equivalents, or 760 new hires. The Office of New Drugs has swelled by 26 percent, or 193 full-time equivalents.

Most of these hires came in the last year; under Bush, the FDA had 700 vacancies that remained unfilled. The FDA plans to hire more than 1000 more employees agency-wide in the coming year and expects reviews by CDER to pick up as new employees get trained in.

The number of black box warnings added to drug labels dropped from 56 to 31, but the number of early warnings--those issued to consumers at the first indication that there might be a serious problem with a certain medication before causality has been established--more than doubled.

This might indicate that the FDA is invested in becoming more transparent, letting consumers know when it has information rather than keeping quiet about it until the problem has caused enough deaths or damage to establish causality.

Other FDA initiatives under President Obama:

January (2009)--FDA sets guidelines for drug and food importations.

March--Enters into collaboration with 8 academic/research institutions to explore nanotechnology initiatives for medical uses

April--Launches plan to review all medical devices approved before 1976

June--Establishes a transparency task force to identify ways for the agency to become more transparent, a major reversal from the secrecy of prior years.

August--Launches initiative with the European Medicines Agency to establish "good clinical practices"

September--Releases strategic plan for risk management

December--Launches widget to address pet health and safety, so pet owners can get rapid information on any concerns with tainted food or illnesses (Recommend all the Pootie and Woozle owners get this!)

December--Launches initiative to study the safety of medications during pregnancy

January (2010)--Unveils phase I of transparency initiative

In addition, the FDA has been doing its job, launching numerous raids on companies that fail to abide by safety standards and recalling numerous products for safety reasons or bogus health claims. Already this month, the FDA has shut down 3 manufacturers of food products with unsanitary conditions.

Also, this FDA approved the first cancer drug for dogs. This, the alert application, and the section on the site about pets and animals, suggests that this FDA recognizes that pets are an important part of many Americans' lives.

The one disappointment in the FDA is its recommendation against the reimportation of drugs from outside the US, which they say is for safety concerns. President Obama says his long-held support of drug reimportations remains firm. As a Senator, he proposed legislation to allow drug re-importation.

The proposed healthcare legislation also provides an avenue that would, for the first time, allow the FDA to establish a process for approving generic biopharmaceuticals. While there are quibbles about how long exclusivity should be maintained, it is still imperative to establish this process to ensure that American consumers will get access to generic biopharmaceuticals in the future.

With Pfizer now investing in the "generics" market and several other Big Pharma companies looking to do the same, we may see Big Pharma less engaged in the fight to keep a long timeline against patent expiration.

There is much more to be done, but this agency is clearly headed in the right direction thanks to strong leadership from individuals who place science ahead of ideology. This is a clear departure from the previous administration and one that will benefit many Americans for years to come.