Obama approves law to ban synthetic drugs

  • Article by: KEVIN DIAZ
  • Star Tribune
  • July 9, 2012 - 8:13 PM

President Obama signed sweeping legislation Monday that bans dangerous synthetic drugs, attacking a national epidemic that killed a Minnesota teenager last year.

The synthetic drug provisions, championed by U.S. Sen. Amy Klobuchar, D-Minn., were part of a broader initiative backed by a bipartisan group of Minnesota lawmakers expediting the Food and Drug Administration's approval of new drugs and medical devices, a priority for Minnesota's medical technology industry.

A rare bipartisan majority in Congress, including Klobuchar, fellow Democrat Al Franken and Minnesota Republican U.S. Rep. Erik Paulsen, also lent solid support to a provision requiring prescription drug manufacturers to give early notification to the government of potential shortages of critical drugs.

"In Minnesota and across the country, we are seeing more and more tragedies where synthetic drugs are taking lives and tearing apart families," Klobuchar said. "Today's action means that this critical legislation to give law enforcement the tools they need to crack down on synthetic drugs is finally the law of the land."

Law enforcement officials in Minnesota and other states have been calling for congressional action to combat the epidemic of designer drugs like 2C-E, which is believed to be responsible for the death of 19-year-old Trevor Robinson last year in Blaine.

A subsequent Star Tribune investigation found that the drugs are often marketed as "legal" alternatives to illicit drugs like cocaine and methamphetamines. But they can have equally devastating consequences.

Klobuchar cited Robinson's death in pushing for a ban on harmful chemicals in synthetic drugs such as 2C-E, a synthetic hallucinogen. The law signed Monday also makes illegal certain chemicals found in synthetic marijuana, often referred to as "K2" or "Spice," as well as the sale of synthetic drugs sold and marketed as "bath salts" that have a similar effect on the body as cocaine and methamphetamine.

Speeding new treatments

The $6.4 billion law also nearly doubles the industry fees paid to fund the FDA approval process. Analysts say it will have major implications for Minnesota's burgeoning medical device industry, allowing it to get products to market quicker.

Paulsen said the law will streamline and modernize the FDA to make it more rigorous and relevant.

One provision, championed by Paulsen, Franken and Klobuchar, relaxes conflict-of-interest regulations that slow expert reviews of new medical devices submitted for FDA approval. Franken also championed a measure encouraging medical device makers to develop treatments for rare diseases, making it easier for patients with those diseases to get treatment.

"Minnesotans will have faster, safer access to innovative and potentially life-saving medical devices," Franken said.

One provision that didn't make it into the final bill was a Franken initiative that would have allowed imports of low-cost Canadian prescriptions.

While some consumer watchdog groups have warned of safety concerns, bipartisan majorities in both chambers of Congress were persuaded by patient-advocates and industry experts that many current FDA regulations are unnecessarily burdensome.

The synthetic drug provisions also had some opponents, including Rep. Keith Ellison, D-Minn., who raised civil-liberties concerns.

More than 30 states, including Minnesota, have banned various synthetic drug compounds, but new ones constantly emerge in a market that is spread nationwide via the Internet. Congress decided that law enforcement needed a national response.

Kevin Diaz is a correspondent in the Star Tribune's Washington Bureau. Twitter: StribDiaz.

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