The pharmaceutical industry is helping state law enforcement officers track sales of a popular over-the-counter decongestant as part of a crackdown on “smurfing,” a way of collecting a key ingredient in the illegal drug methamphetamine.
Authorities hope the industry-funded tracking system will tip the advantage in their favor in a long-running battle with meth cooks.
Pharmaceutical companies have been pushing to expand the tracking system amid growing calls to require prescriptions for pseudoephedrine, the legal decongestant that is also used to make meth.
South Carolina is among 10 states that have passed laws adopting NPLEx, the industry’s system to track pseudoephedrine. Two states have begun requiring prescriptions for the drug, often marketed as cold and allergy medicine.
The decongestant remains available without a prescription in S.C., although retailers must keep it behind the counter.
Pharmacies statewide have been recording who is buying the drug and how much since 2006, but they had no means of sharing the information with each other until recently.
NPLEx, or National Precursor Log Exchange, puts all the purchases in one database, making it easier to track sales at different pharmacies. When a customer tries to buy more than the limit, retailers receive a recommendation to deny the sale, as a message is sent to the State Law Enforcement Division.
Sales of more than 6,000 boxes of pseudoephedrine have been blocked since the system went live in the state on Jan. 1, according to SLED records.
“Every single time a product gets blocked, you could be preventing a meth lab from happening,” said Mandy Hagan, the director of state government relations for the Consumer Healthcare Products Association, the group leading the NPLEx lobbying effort.
Privacy Rights Clearinghouse and the Electronic Privacy Information Center said they aren’t watching NPLEx but that the system raises general concerns about privacy of medical records.
“When personal information is collected into a database, there is always a chance of some secondary use,” said Tena Friery, research director for the San Diego-based clearinghouse.
Federal law makes clear that information gathered by NPLEx is accessible to law enforcement only, Hagan said.
Kentucky, the state that pioneered the system, is blocking the sale of 10,000 grams of pseudoephedrine per month — enough to make 5,000 grams of meth, Hagan said. Meth lab incidents in S.C. fell from 199 to 26 from 2004 to 2007 and then began climbing back up, reaching 77 in 2009, the last year for which data is available, according to the Drug Enforcement Administration.
Each lab costs an average of $2,200 to clean up and is often full of toxic chemicals that can sicken officers or explode, according to an audit by the U.S. Department of Justice’s inspector general.
The state law that brought the tracking system to S.C. also lowered the caps on purchases of pseudoephedrine to 3.6 grams per day and 9 grams every 30 days. Ephedrine and phenylpropanolamine are also subject to the limits.
Customers who buy or possess more than the limit face up to five years in prison and a $5,000 fine for a first offense under the new law. Multiple offenses could result in a 10-year prison sentence or a minimum fine of $10,000.
Dr. Emmanuel Sarmiento of the Allergic Disease and Asthma Center in Greenville said it is rare for patients to need more than 240 milligrams a day.
Patients who do need more can get a letter from a doctor exempting them from state limits, he said. Taking high doses of pseudoephedrine for a sustained period can lead to heart arrhythmia and prostate problems, he said.
Oregon and Mississippi are the only states that require a prescription for pseudoephedrine. State Sen. Mike Fair, R-Greenville, said S.C.’s meth problem left the state with the choice between the tracking system and requiring prescriptions. Only if NPLEx turns out to be an “abject failure” does he expect lawmakers to revisit the prescription idea.
Walgreens, CVS, Rite Aid and Wal-Mart are among the retailers using NPLEx, according to SLED.
Retailers face up to three years in prison and $10,000 in fines for violating the law.
Purchases follow customers over state lines. North Carolina doesn’t use the tracking system, and Georgia lawmakers are considering it, Hagan said.
Pharma Ind expects level playing field in excise duty
According to Indian Drug Manufacturers Association President and Pharmexil Vice-Chairman N R Munjal, the Budget should address the need for research and development (R&D) and the anomalies in the excise duty for the pharma sector.
He said the Union Budget for the last four years did not focus on the push required for R&D in the pharma sector.
“India ranks third in volume and 13th in value in the global pharma market, so there is a tremendous scope for improvement. Since IPR (intellectual property rights) are intangible assets, a measly funding is earmarked for such projects.”
He added, the PPP (public-private partnership) mechanism for the pharma business was quite cumbersome. Most of the pharma companies are flourishing under the PPP model where private universities, government labs and pharma companies collaborate for R&D. We are lagging in this, he rued.
Surya Pharmaceutical Limited Managing Director Rajiv Goyal said, the disparity in the excise duty on finished goods and raw material (the excise duty on raw material is 10.3 per cent and on output is 4 per cent) should be removed. This is the only industry with a differential excise duty on input and output cost.
This has specifically hit the units in tax-free zones as the units located in other parts can obtain 10 per cent modified value added tax to save the tax burden.
Himachal Drug Manufacturers Association Chairman Sanjay Guleria said, the Union Budget should revise the Drug Price Control Order (DPCO). There is a proposal of including 300 drugs under the category of essential drugs, presently there are 72 drugs under this.
Due to the scarce availability of skilled labour, the cost has been rising for drug manufacturers, still Indian drugs are the cheapest in the world.
The government should make provisions for the development of the pharma sector by allocating more funds for R&D and streamlining the tax structure, he finished.
SCOLR Pharma, Inc. Retains Nicholas Hall & Company
SCOLR Pharma, Inc. (OTC Bulletin Board: SCLR) today announced that it has retained Nicholas Hall & Company, a company providing complete support services to the global consumer healthcare industry, to introduce SCOLR to pharmaceutical companies, distributors and retailers that are interested in utilizing the Company’s proprietary technology to develop OTC or prescription pharmaceutical or nutritional products.
With more than 35 years’ experience of strategic planning, market analysis and product placement, Nicholas Hall & Company, possesses detailed knowledge of the consumer healthcare market worldwide.
Stephen J. Turner, SCOLR Pharma’s President and CEO, said, “Nicholas Hall & Company has a long and successful track record of assisting specialty pharma companies with their partnering and marketing strategy. We believe their deep relationship with many of the world’s leading pharmaceutical and over-the-counter (OTC) consumer products companies will be very valuable to SCOLR as we seek to partner and expand the utilization of our technology in OTC and prescription products.”
About SCOLR Pharma:
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company focused on applying its formulation expertise and patented CDT platforms to develop novel prescription pharmaceutical, over-the-counter, and nutritional products. SCOLR’s CDT drug delivery platforms are based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products.
Forward looking statements:
This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning the anticipated value of services to be provided by Nicholas Hall & Company, and the possibility of transactions involving the use of SCOLR’s proprietary technology. These forward-looking statements involve risks and uncertainties, including activities, events or developments that SCOLR expects, believes or anticipates will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements, including the willingness of such of third parties to partner with SCOLR on acceptable terms, or at all, competition from larger and better funded pharmaceutical companies, SCOLR’s ability to manage its liquidity and obtain financing necessary to continue its operations and, global economic conditions. Additional assumptions, risks and uncertainties related to SCOLR’s business are described in detail in its registration statements, reports and other filings with the Securities and Exchange Commission, including the “Risk Factors” set forth in its Annual Report on Form 10-K, as supplemented by its quarterly reports on Form 10-Q. You are cautioned that such statements are not guarantees of future performance and that actual result or developments may differ materially from those set forth in the forward-looking statements. SCOLR undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstance.