Yesterday, I was asked by Ed Silverman of STAT NEWS’ Pharmalot for my thoughts about a report by the Office of Inspector General, Department of Health and Human Services (OIG). The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). In short, as reported in STAT, OIG found that seven out of 44 drugs audited could not be traced back to the manufacturer in the manner required under the DSCSA. Add to that, the physical locations of 21 drugs could not be determined. Since most drugs subject to DSCSA are made overseas and imported, Mr. Silverman wanted to know if this audit impacted drug importation proposals and plans in the works to lower drug prices. The answer is probably no. The report appears to be a worthwhile effort to test compliance with DSCSA. However, use of the word “legitimate” is found in the DSCSA, and that word is often misused by opponents of drug importation and international online pharmacies – and that got me thinking. I’m sick of that word.(more…)Tagged with: ed silverman, Eliquis, LegitScript, NABP, OIG
In 1976, reggae legend, Peter Tosh, released his song “Legalize It” – calling for the legalization of marijuana. In it, he sings “legalize it, don’t criticize it.” Needless to say, that’s already becoming our reality in the U.S. where, to varying degrees, many states have made pot legal. The federal government has begrudgingly accepted dissension in the ranks of states. Yes, there are rumblings that under Attorney General Jeff Sessions things are going to change. We’ll see.
This week, journalist and pharmaceutical industry analyst, Ed Silverman, from Stat News, published an opinion article called “It’s time to make it legal for Americans to order prescription drugs from abroad.” Unlike the downpour of op-eds against importation sponsored by drug companies, Silverman has no financial interest in this.
To be intellectually honest, Silverman’s call to action is qualified. He seems to be saying to “legalize it,” but he’s not necessarily advising that we not “criticize it.” There are real threats from counterfeit and otherwise substandard drugs that need to be addressed in reforming the law. Dr. Aaron Kesselheim, professor of medicine at Harvard, offers his own thoughts in Silverman’s piece: “We should be able to address this safety issue…To not have the conversation and instead say there’s no way to import medicines safely is a cop-out.” (more…)Tagged with: boston globe, drug imports, ed silverman, legalize it, sanders, statnews