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 laws.
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 product.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.
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.