PHARMACY

FDA asks for $2.4 billion in proposed 2009 budget

BY Drew Buono

WASHINGTON The Food and Drug Administration has released its proposed budget for fiscal 2009 from the Bush administration. The agency is asking for nearly $2.4 billion “to protect and promote public health.” This amount represents a 5.7 percent increase over the budget the FDA received last year.

The fiscal 2009 request covers the period of Oct. 1, 2008, through Sept. 30, 2009, and includes $1.77 billion in budget authority and $628 million in industry user fees. The FDA will use some of this money to hire an additional 526 members to its staff.

One of the areas in which the FDA is proposing a budget increase is medical product safety and development, which includes testing the safety of drugs for humans and animals and the ability of the FDA to closely monitor the development of these products. The proposed budget for this area would increase $17.4 million to $887 million.

The agency also is asking for the expansion of it generic drug user fee to be able to offer more generic drugs to the public. A press release from the agency stated that this initiative “advances Medicare Rx objectives by promoting the availability of lower-cost generic alternatives,” and by approving more generic drugs, it would support the Medicaid Modernization. The amount for this initiative would be more than $16.6 million.

In response to the FDA’s proposal, the Generic Pharmaceutical Association president and chief executive officer Kathleen Jaeger said that she agreed with the FDA on bringing more affordable drugs to the market for consumers, but more needs to be done.

Jaeger asked for the agency to now look into the development of biogeneric drugs and to create a clear and safe pathway so that these important drugs can be brought to the American market. She stated that it is in the best interest for everyone to look into approving more generic drugs.

“Bringing generic medicines to market in a timely manner is a win-win for the federal government, the generic industry and, most of all, consumers. In 2008, we should all work together to reach our shared goal of increased access by providing supplemental funding for the Office of Generic Drugs; enacting legislation to create a workable approval pathway for biogenerics; approving free trade agreements, like the most recent free trade agreement with Peru; and removing long-standing barriers to access, such as authorized generics and citizen petitions,” Jaeger said.

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PHARMACY

Study shows no link between ADHD medication and drug abuse

BY Diana Alickaj

WASHINGTON A new report published in the March issue of the American Journal for Psychiatry states that children who are given psycho-stimulants for attention deficit-hyperactivity disorder are not more susceptible to begin abusing drugs and alcohol than their peers.

ADHD is a disorder that includes systems of inability to focus, hyperactivity and impulsiveness. According to the Wall Street Journal, 9 percent of children have ADHD in America, but only 32 percent get the medication needed to treat it.

The report was funded by the National Institutes of health and was designed by the Massachusetts General Hospital investigators whose main goal was to make sure to cover all necessary angles in order to receive the correct data for the relationship between drug abuse and ADHD medication.

The researchers interviewed 112 men between the ages of 16 and 27, a decade after they were diagnosed with ADHD and asked about their consumption of tobacco, alcohol, drugs and the type of medication they used. The study concluded that there was no relationship between substance abuse and the prescription ADHD medicines.

“This study is a continuing effort to explicate the factors that mediate risk. It is methodologically sound and suggests that, as always, things are more complicated than we want them to be. The study demonstrates that the use of psycho-stimulants for ADHD children does not increase the risk for substance abuse in adulthood, but it also suggests there is no protective effect,” said Jon Shaw, director of the Division of Child and Adolescent Psychiatry and Behavioral Science at the University of Miami.

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FDA rejects Labopharm’s Tramadol after response to second approvable letter

BY Drew Buono

WASHINGTON Labopharm’s appeal of a second approvable letter from the Food and Drug Administration for a once daily formulation of its pain drug Tramadol has been rejected by the agency.

The director of the Center for Drug Evaluation and Research’s Office of New Drugs, John Jenkins, “has suggested additional statistical analysis of existing data as a means to potentially satisfy the agency’s requirements,” according to Labopharm.

The method Jenkins is proposing is different from the method the FDA requested following its first approvable letter in May 2007, the company said. Jenkins also recommended the company meet with the agency prior to any resubmission.

Labopharm is trying to introduce the once-daily formulation of tramadol, which is its lead product, in various international markets, including Canada, France, Germany, Spain, Italy and the UK.

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