These joint efforts call for drug companies to share data on test results and best practices, something industry is generally
reluctant to do. To create the C-Path safety consortium, dozens of lawyers had to define a pre-competitive area for collaboration
that avoids anti-trust violations. Participants believe it is in everyone's interest to identify better markers for drug safety
and disease, says Shannon. But such projects could collapse if participants don't pull their weight or wrangle over intellectual
property. And Critical Path could lose its impetus under less supportive FDA leadership.
Patches and Inhalers
Another opportunity for collaboration involves developing innovative approaches for testing and producing novel drug dosage
forms. The Critical Path calls for new testing instruments for delivery systems, such as patches, liposomes, topicals, and
nasal and pulmonary inhalers.
Interest is especially keen in this area, since FDA has recently approved several new delivery products, including the first
inhaled insulin, Pfizer's Exubera, and a patch treatment for major depression, Somerset's Emsam (selegiline). A patch for
ADHD was approved last month.
Such products are popular because health plans and patients appear willing to pay a premium for products they can administer
at home with less discomfort and less risk of safety problems. Drugs may be absorbed better from inhalers and patches, which
means that patients can take smaller doses—which are less likely to create undesirable side effects.
However, recent evidence that heat effects may overly increase drug absorption rates from patches is prompting a closer look
at new dosage forms. FDA's Office of Testing and Research is studying ways to ensure the quality and safety of patches and
inhaled drugs; it is studying patch adhesion to skin, in vitro test methods to assess drug release from patches more efficiently,
and how to set standards for evaluating factors affecting the quality of inhalation drugs.
Such analysis is likely to facilitate the approval of generic versions of innovative dosage forms. FDA recently approved the
first generic allergy nasal spray from Boehringer Ingelheim's Roxane Labs, a version of GlaxoSmithKline's Flonase (fluticasone
propionate). Reviewing this first generic nasal spray-suspension product was a challenge for FDA's Office of Generic Drugs,
and points to the need for additional standards for new delivery systems. In a speech to the Generic Pharmaceutical Association
in February, FDA deputy commissioner Scott Gottlieb pointed out that most topical creams are difficult to evaluate for efficacy
with standard in vitro analysis and bioequivalence testing. And liposomes, which can target a therapy to selected tissues,
require new methods for assessing bioequivalence.
Resolution of scientific and technical issues related to generic drug bioequivalence is likely to remove some roadblocks to
marketing innovative generic products. GSK raised legal and scientific objections to generic Flonase, but gave up after a
negative federal court ruling. Meanwhile, Glaxo had hedged its bets by licensing Par Pharmaceuticals to market an authorized
generic version, an increasingly common strategy for innovator firms seeking to retain some revenues from blockbuster products
facing new generic competition.
The practice, though, has attracted attention from federal watchdogs. The Federal Trade Commission recently announced a broad
study on prices and policies related to authorized generics, as requested last year by Senate Finance Committee chairman Chuck
Grassley (R-IA) and two Democrats. In addition, the HHS Inspector General plans to assess the effect of authorized generics
on Medicaid drug pricing and rebates. Congressional committees expect to hold hearings on the topic, with a focus on how authorized
generics should relate to "best price" Medicaid calculations.
The FTC seeks to subpoena wholesale price data, including rebates and discounts, for brand-name and generic drugs from almost
200 pharmaceutical manufacturers. The agency will examine licensing agreements and business plans to assess how authorized
generics affect market entry and prescription drug prices. Pharma has until June to comment on whether the FTC is overburdening
industry by asking so many companies to produce so much information.
Jill Wechsler is Pharm Exec's Washington correspondent. She can be reached at firstname.lastname@example.org