NOVEMBER 15, 2009

NEJM Says Biogenerics Pathway Should Be Shorter
How long should new biologic therapies hold market exclusivity? The New England Journal of Medicine (NEJM) recently weighed in on this question, arguing that 12 years is too long and that the biologics marketplace is ready for a shorter period before generic equivalents can be introduced. Exclusivity rights for biologics marks one of many controversial issues emerging in the current debate over health care reform. In the NEJM commentary (October 14, 2009), the authors write in favor of an amendment to the reform legislation, many versions of which carry a 12-year exclusivity period: "President Obama should encourage amendments that would give the FDA the mandate to evaluate and approve biosimilar drugs in a reasonable period, starting, as with small-molecule products, 5 years after the approval of the original drug." The Obama administration has previously indicated support for a 7-year exclusivity period as one way to save on health care expenditures, a compromise that holds the support of the Generic Pharmaceutical Association. Supporters of the 12-year exclusivity period argue that protection from competition is fair because the development costs for biologic products are higher than they are for other medications.

Bill Would Close Labeling Loophole
US Senators Jeanne Shaheen (D, NH) and David Vitter (R, LA) have introduced legislation intended to close a loophole used by brand drug companies to delay generic drugs from entering the market. As the law currently stands, when brand name manufacturers make labeling changes, generic drug labeling must reflect the change prior to approval and introduction to the market. This law was created with patient safety in mind, so that all current drug safety and warning information would be reflected on the label. The bill's sponsors note, however, that many companies make last-minute changes to labels, not because of safety concerns, but to delay the introduction of generic alternatives by weeks or months. The proposed legislative remedy (S 1778) would provide generic drug companies with a 60-day grace period to submit new labeling for approval and marketplace distribution. The bill includes safeguards so that in the event the new labeling truly represents a safety issue, the FDA would prohibit the medication from entering the market until the generic manufacturer updated the labeling.

What to Do About Pay-for-Delay?
The Senate Judiciary Committee's recent vote in favor of a measure (S 369) to prevent drug companies from paying their competitors to keep cheaper generic equivalents off the market has sparked concern from the generic companies' leading advocacy group, worried that the bill has the potential to "sweep good settlements in with the bad."
The Generic Pharmaceutical Association (GPhA) argues that the measure is flawed, in part because it fails to include a score from the Congressional Budget Office which would help determine whether the bill "could potentially have the unintended effect of benefiting the brand industry and ultimately hurting consumers by keeping more affordable generics from getting to the market in a timely manner," according to a GPhA statement issued after the vote. "The generic industry continues to believe that Congress can successfully address bad settlements without harming pro-consumer, pro-competitive settlements in the process."

Survey Finds Americans Don’t Know Enough About Generic Option
A survey by UnitedHealth Group's Prescription Solutions has found that many Americans have limited knowledge of generic drugs, with many still believing that the most expensive drug s always the most effective one.
The survey of 1000 adults was conducted by Opinion Research Corp. -Among its key findings:
• Nearly one third of Americans do not know or believe that generic drugs have the same active ingredients and effectiveness of brand name drugs.
• Only 31% of survey respondents knew that a brand name drug cost 50% to 70% more than its generic counterpart.
• Doctors and pharmacists play a key role in influencing the use of generics. Of respondents who take generic drugs on a weekly basis, 64% said their physician recommended generics, and 43% said their pharmacist recommended them.
The impact of the economy on patient adherence also emerged in the survey findings, with more than 1 in 4 (27%) respondents reporting having delayed filling, not filled, or not taken as directed a prescription medication in order to save money. Of those who do not take generic drugs on a weekly basis, 58% said they would if their pharmacist brought a generic to their attention as a less expensive, identical substitute.

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