On Monday, June 18, 2012, the House is scheduled to consider H.R. 3668, the Counterfeit Drug Penalty Enhancement Act of 2011, under a suspension of the rules requiring a two-thirds majority for approval. The bill was introduced on December 14, 2011, by Rep. Patrick Meehan (R-PA) and referred to the Committee on the Judiciary, which held a mark up and reported the bill by voice vote on June 6, 2012.

H.R. 3668 would amend the federal criminal code to establish criminal penalties of a fine, imprisonment for no more than 20 years, or both, for trafficking in counterfeit drugs.  The bill would state that nothing in the Act shall be construed to apply to a drug solely because the drug is manufactured in or imported from a foreign country.

According to the House Committee on the Judiciary, Rep. Pat Meehan introduced the bill to increase criminal penalties for the trafficking of counterfeit drugs.

Current law prohibits trafficking in counterfeit goods.  This statute is primarily concerned with goods that are trafficked using counterfeit marks or labeling.  However, counterfeit drugs are more serious.  Counterfeit drugs present a real health risk to consumers, not merely a financial loss to the manufacturer or mark holder.  While current law technically includes counterfeit drugs, the law does not expressly prohibit trafficking in counterfeit drugs and carries a maximum penalty of only 10 years.

In late February 2012, drug manufacturer Roche announced that a counterfeit form of the cancer drug Avastin had been imported and distributed to doctors in the U.S.  The counterfeit versions of the drug contain a variety of chemicals, ranging from starch and salt to solvent chemicals like acetone, but not the active ingredient found in the genuine drug.

According to the Washington Post, “British regulators have confirmed that 41 vials of fake Avastin were shipped to the U.S.  Five have been recovered while 36 which are still missing.  Authorities in Europe have traced the counterfeit product back through distributors in Britain, Denmark and Switzerland. The original country of origin is still unclear.”

“Experts say gauging harm from a counterfeit cancer treatment is very difficult because drug infusions are spaced out over weeks and months. A colon cancer patient, for example, might receive 18 to 20 Avastin infusions over six months. Missing one dose seems unlikely to have a dramatic effect on survival odds, but it’s not provable either way.”

Even with a 10 year maximum penalty, the actual sentences imposed under the existing counterfeit goods statute are dramatically lower.  According to the U.S. Sentencing Commission, between FY 2006 and FY 2010, there were 385 federal prosecutions for counterfeit goods (18 U.S.C. § 2320).  The median sentence was 17 months; the mean sentence was only 10 months.

There was no CBO score at press time.