Pharmaceutical Companies Reformulating Cold Medicines to Eliminate Pseudoephedrine

Under pressure from state governments and local law enforcement agencies, the pharmaceutical industry is changing the chemical formulation of cold and allergy OTC medicines to prevent their ingredients being converted into Methamphetamine.

“This is the direction we’re moving,” said Elizabeth Assey, spokeswoman for the Consumer Healthcare Products Association in Washington, D.C., a lobbying organization for the cold medicine industry.

Pseudoephedrine, a main ingredient in a number of over-the-counter drugs such as Sudafed and Sinutab, can be extracted by boiling down cold medicines. Toxic chemicals are then used to turn the substance into meth.

More than a dozen states already have restricted access, either by allowing only pharmacies to sell drugs with pseudoephedrine or making retailers sell them from staffed counters. A May report by the Office of National Drug Control Policy found a 50 percent drop in the number of meth labs in Oklahoma and Oregon, two of the first states to enact such restrictions.

But law enforcement officials and others believe that reformulating the drugs can reduce the problem even more, by helping shut down the small labs operating nationwide.

Pfizer Inc., the manufacturer of Sudafed and other leading pseudoephedrine products, plans by January to reformulate up to half of them with phenylephrine.

Leiner Health Products, which supplies generic cold and allergy drugs to retail chains such as Costco, Target, Walgreens and Wal-Mart, began shipping new products containing phenylephrine in June.

McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson & Johnson, also is considering reformulation of a variety of its products, along with other major manufacturers, including Wyeth and Schering-Plough.

And the world’s largest producer of phenylephrine — Boehringer-Ingelheim of Germany — says it can boost production capacity for the substitute ingredient by enough so the entire U.S. supply of pseudoephedrine could be replaced by 2006.

However, the t pharmaceutical companies are moving cautiously to make sure substitutes are effective, and to await proposed federal legislation – Combat Meth Act – that could affect how they reformulate some of their products, said Assey, of the Consumer Healthcare Products Association.

“It’s the first step in a long process, from an industry standpoint,” she said.

Phenylephrine differs from pseudoephedrine by a single pair of oxygen and hydrogen atoms, a tiny but important difference that makes it virtually impossible to transform phenylephrine into methamphetamine.

“Structurally, when just looking at the chemistry, they are very, very similar,” said Kate Farthing, an Oregon Health & Science University pharmacist.

But if cooks at illegal labs try to convert phenylephrine into methamphetamine, they get only a useless variation, Farthing said.

Pseudoephedrine

Vs. Phenylephrine

Flap looks for the drug companies to drag their feet while exerting their lobbying muscle on the federal Combat Meth Act.

However, the states like Iowa and local law enforcement agencies who have been dramatically impacted by this Meth scourage will keep the pressure on the Congress.

A change in formulation would end the spread of the MOM and POP labs.

Now, what will the Congress do about the importation of Methamphetamine from Mexico?