As revenues continue to be eroded by generic competition for numerous blockbuster drugs, pharma companies are ramping up efforts
to delay marketing of copycat products and to protect new therapies moving through the pipeline. Brand manufacturers have
to contend with insurers, payers, and drug plan operators, who eye increased generic drug use as key to cutting healthcare
costs. And the Food and Drug Administration is under pressure to do all it can to speed new generic drugs to market.
Contention has emerged on the international trade front, where generic firms are contesting pharma efforts to include hefty
exclusivity provisions in the Trans-Pacific Partnership (TPP) agreement and other trade pacts. At home, discord has been mounting
over actions by brand manufacturers to block access to drug supplies needed for bioequivalence testing by generics makers.
Pharma companies point to risk evaluation and mitigation strategies (REMS) that impose strict controls on distribution of
certain medicines, and that strategy seems to extend to products without limited distribution requirements. FDA officials
have stated that REMS provisions are not intended to block generic drug development. Lawsuits are moving forward, with the
Federal Trade Commission (FTC) supporting generic company claims that blocking access to test supplies violates antitrust
Citizens' petitions and lawsuits continue to pit manufacturers against each other and FDA. Teva Pharmaceutical, for example,
is appealing a recent court decision denying patent protection for its lead multiple sclerosis treatment Copaxone, which opens
the door to generic competition in May 2014. Teva could retain market share longer if FDA requires full, placebo-controlled
clinical trials on generic versions, which Teva says are needed to ensure the safety and immunogenicity of this hard-to-characterize
Similarly, GlaxoSmithKline faces generic competition for its asthma treatment Advair (fluticasone/salmeterol) following FDA
publication of guidance last month for developing bioequivalent versions of this blockbuster inhaled powder. FDA calls for
some clinical trials—in addition to in vitro and pharmacokinetic studies—to document bioequivalence. But Sanford Bernstein
analyst Tim Anderson predicts generic versions of this lead Glaxo product by 2016, noting that FDA gives Sandoz and other
generics firms three years to "iron out all the wrinkles" in their development programs.
FDA officials have come down hard on brand companies that file late or trivial citizens' petitions to delay generic drug approvals,
as seen in its recent blast of Novartis for "misuse of the petition process" in seeking to block generic versions of bone-loss
drug Reclast (zoledronic). The agency's harsh language, notes Hyman, Phelps, McNamara attorney Kurt Karst (fdalawblog.net/, August 28, 2013), could fuel private litigation.
Meanwhile, pharmacy benefit managers (PBMs) are working hard to promote generic drug use. The Pharmaceutical Care Management
Association issued a report in May (2013) projecting $75 billion in savings for Medicaid pharmacy programs over the next decade
from increased use of generics, as well as other formulary features; reduced pharmacy dispensing fees; and the formation of
limited pharmacy networks.
A prime target of payers and PBMS are co-pay coupons from innovator firms, which have become a popular alternative to drug
samples for promoting new therapies. The coupons usually cover all or part of the patient's co-pay or coinsurance for a drug
to equalize outlays for a new therapy compared to older brands or generics.
But the strategy is costly in the long run for plans and payers, according to a recent article in the New England Journal of Medicine (August 28, 2013) that analyzed some 374 brand-name medicines offering coupons, 62 percent facing competition from generics
or cheaper brands. While patients may benefit greatly from coupons for essential life-saving medicines that have no alternatives,
the authors note that insurers still have to pay the higher cost of the promoted medicine. And that can add up when patients
with chronic conditions become reluctant to switch to a less expensive generic or brand once comfortable with the new drug.
Co-pay coupons are regarded as kick-backs in federal health programs, and the HHS Inspector General is examining whether Medicare
Part D plans have sufficient safeguards in place to ensure that beneficiaries don't use them. The Senate Finance Committee
also has examined whether coupons encourage beneficiaries to choose more expensive brand drugs over low-cost generics and
thus cause Medicare to pay more than necessary.