“The industry/government collaboration on [federal] Quality by Design [guidelines] should finally start to manifest itself in specific new capabilities and processes,” says the pharma vice president for automation software vendor Aspen Technology Inc. (www.aspentech.com), Burlington, Mass.
The good news is, it’s win-win, Hintlian says. “Big pharma will see benefits in quality management, batches being right the first time, etc. Regulatory agencies will see NCE [new chemical entity] submissions made with a better process understanding.”
Better regulatory understanding comes through better evaluation tools. “As science evolves, so must methods used by regulatory agencies to review products developed by America’s biopharmaceutical research companies,” says Washington, D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA, www.phrma.org). “That is why reauthorization of the Prescription Drug User Fee Act (PDUFA) is a top PhRMA priority.” In 2012, Congress must reauthorize PDUFA to prevent disruptions in the new-medicines evaluation process.
Regardless, prices rise. In a March 2012 report—“Rx Price Watch Report: Trends in Retail Prices of Prescription Drugs Widely Used by Medicare Beneficiaries, 2005 to 2009”—the AARP’s Public Policy Institutes says, “[Our] first look at retail prices for a combined set of [514] widely used prescription drugs finds that the cumulative change in retail prices was almost double the rate of inflation between 2005 through 2009.”
How does that affect a consumer taking a prescription drug long-term? “This translates into an increase in the annual cost of therapy of more than $1,000 over the same time period,” says the Washington, D.C.-based AARP (formerly American Association of Retired People, www.aarp.org). AARP attributes its findings entirely to drug price growth among brand and specialty drugs, which, the association says, “more than offset substantial price decreases among generic drugs."
C. Kenna Amos, [email protected] is an Automation World Contributing Editor.
