Congressional Bill Establishes Biogenerics Approval Path
Washington, DC (Feb. 14)—A congressional team has reintroduced the "Access to Life-Saving Medicine Act," which establishes a process through which
the US Food and Drug Administration (FDA, Rockville, MD,
http://www.fda.gov/) can approve generic copies of biologic drugs. Some congressional leaders are calling for the bill to be attached to the
Prescription Drug User Fee Act, slated for reapproval this year, but no plans for this have been set. If approved, the act
would provide FDA with the process for comparing biogenerics and the respective innovator drugs without the need for the generics
firm to conduct clinical trials.
The bill was proposed during a previous session of Congress, but because the bill was not passed at the end of the session,
it had to be reintroduced.
Under this law, FDA would have the "discretionary authority in selecting certain studies and tests needed to approve biogenerics
or follow-on drugs."
On his Web site, Rep. Henry Waxman (D-CA) stated, "Introducing fair competition for biotech drugs is essential to keep life-saving
treatments affordable. "The Generic Pharmaceutical Association also has stated its strong support of the bill, saying it will
provide an abbreviated approval pathway for safe, effective, and affordable biogenerics to consumers.
Green Chemistry Reduces Costs and Waste
University researchers are investigating green-chemistry applications that could reduce costs and improve efficiencies for
pharmaceutical manufacturers. Ecologically sustainable techniques being studied could save industry money by reducing pollution
and waste, simplifying manufacturing processes, using fewer resources, and improving product yield.
Catalysts and separations
Separations can account for as much as 80% of the cost of chemical processes, and the solvents used often harm the environment.
Homogeneous catalysts, however, could be recovered and recycled easily and safely using solvents called gas-expanded liquids.
Professor Charles A. Eckert, PhD, of the Georgia Institute of Technology (Atlanta, GA,
http://www.gatech.edu/) explains that gas-expanded liquids are miscible gas–liquid mixtures that allow scientists to perform reactions at low pressures.
Researchers first cause a reaction in a homogeneous solution and then add a gas to the solution. The gas splits the solution
into two phases to "separate the product in one phase and the catalyst in the other phase for reuse," Eckert says. Because
this technique allows catalysts to be recovered, it is economical and minimizes waste.
Scientists could reduce waste further by using smart solvents. Smart solvents can be modified to replace less-efficient solvents
with undesirable characteristics. According to Eckert, scientists can "turn a switch, literally," to cause smart solvents
to exhibit a step change in properties. Eckert's research team created a smart solvent with properties similar to those of
dimethyl sulfoxide, but with a low boiling point. Because the solvent, called piperylene sulfone, is easy to separate from
a product and reuse, its application could lower costs and minimize waste.
Metabolic and biochemical engineering
Active pharmaceutical ingredients (APIs) can be found in nature, but natural APIs may be present only in low concentrations.
Extracting them is often difficult, expensive, and disruptive to sensitive ecosystems. Synthesizing the APIs is an alternative,
but the process can be complicated and expensive.
Certain organisms produce enzymes that catalyze reactions yielding APIs. Saving the organisms to reuse catalytic enzymes would
reduce the costs of drug synthesis. Tonya Peeples, professor at the University of Iowa (Iowa City, IA,
http://www.uiowa.edu/), seeks to use biochemical engineering to develop solvent-tolerant microbial systems for aerial oxidations and aromatic compounds.
Solvent-tolerant organisms could withstand organic solvents and could catalyze more reactions to increase yield.