Generic News Capsules

Generic Heart Meds Equally Good, Study Finds

A recently released analysis of 9 subclassesof cardiovascular medications hasfound no evidence to support the notionthat brand name drugs used in cardiovasculardisease are superior to generics.The analysts came to this conclusionafter examining 47 articles reporting peerreviewedresearch on these medications.

?This scientific review is the latest ina growing number of authoritative statementsfrom the FDA and others provingthat it is safe to substitute an FDAapprovedgeneric medicine for a brandname product,? said Kathleen Jaeger,president of the Generic PharmaceuticalAssociation.

The meta-analysis, reported in theDecember 3, 2008, issue of the Journal ofthe American Medical Association (JAMA),also revealed that a substantial numberof editorials counsel against the interchangeabilityof generic drugs. Among 43editorials, 23 (53%) expressed a negativeview of generic drug substitution.

Jaeger added that, ?it is noteworthy thatthe JAMA article states, ?popular mediaand scientific journals could choose to bemore selective about publishing perspectivepieces based on anecdotal evidenceof diminished clinical efficacy or greaterrisk of adverse effects with generic medications.Such publications may enhancebarriers to appropriate generic drug usethat increase unnecessary spending withoutimproving clinical outcomes.??

Canada Sees Big Savings with Generics . . .

A new report from the Canadian CompetitionBureau estimates that up to $800million a year would be saved if genericdrugs were sold in a more competitivemarket.

The study, ?Benefiting from Generic DrugCompetition in Canada: The Way Forward,?states that the savings will only grow as severalblockbuster brand name drugs comeoff patent in the next 3 years and becomeavailable in generic versions. ?Our reportprovides a timely prescription for change,?noted Sheridan Scott, Commissioner ofCompetition. ?Our study suggests ways tomake the generic drug market work betterfor consumers, businesses, and governments,so we can all get the most value forour health care dollars.?

Data Exclusivity Period Could Be Cut by Half

An analysis by a former senior advisor tothe House Ways and Means Committeehas found that 7 years is enough time togrant biologics manufacturers before biogenericscan come to market, rather thanthe 14 years currently supported by theBiotechnology Industry Organization.

The study by Alex Brill, currently aresearch fellow at the American EnterpriseInstitute, was commissioned by TevaPharmaceuticals USA. ?Alex Brill?s findingsinject a new and much-needed perspectiveon the debate around data exclusivityand biogenerics,? said William Merth,president and chief executive officer ofTeva North America. ?This work underscoresthe importance of finding the balanceneeded to appropriately reward biologicsinnovators while maximizing healthcare savings.?

. . . And European Commissioner Wants More Competition

Neelie Kroes, the European Commissionerfor Competition Policy, says that competitionin the pharmaceutical sector does notwork as well as it should.

In releasing a preliminary report onthe subject in November, she identified3 practices most responsible for delayingor blocking market entry of competitors:patent clustering, a large number oflitigation cases over patents; and patentsettlements that constrain market entry ofgeneric companies.

The report also notes that in 1 year followingentry by generic medicines, pricesare almost 20% lower, and 25% lowerafter 2 years; in a rare number of cases,prices can drop as much as 80% to 90%.

The final report is expected this spring.

Follow-on Biologics Focus of FTC Roundtable

The Federal Trade Commission (FTC)recently hosted a roundtable discussionto address issues of competition and continuedinnovation under a framework forfollow-on biologic drugs, a move manystakeholders see as evidence of growingmomentum to establish a pathway forbiogenerics.

Panelists on the roundtable includedrepresentatives of the FDA, insurers,generic and brand name drug manufacturers,and academia, among others.

?Increased competition in the biologicsmarket will benefit health plans,employers, and federal programs, andmore importantly, will help make specialtymedicines more affordable forpatients, many of whom must take thesemedicines their entire lives,? said DaveGolding, RPh, executive vice presidentfor specialty pharmacy services at CVSCaremark, and one of the roundtableparticipants. ?We support the creationof a federal legislative pathway for FDAapproval of these medicines to provideaccess and savings to patients andpayers.?