As new challenges
to drug safety emerge, Teva works with government officials, industry
partners, patient representatives and other key stakeholders to develop
smart, effective responses. We strongly support efforts to deter drug
counterfeiting and strengthen inspections of domestic and foreign facilities.
• Prescription Drug Anti-Counterfeiting
– Threats to the integrity of the
drug supply represent a national problem that requires a national solution
rather than the current patchwork of state-by-state plans. Real-world
experience shows that counterfeiters typically target high-priced drugs
with strong consumer demand, and deterrent efforts should start with these
at-risk medications. Any anti-counterfeiting system should use proven
technology, be phased in so there is no disruption of patient access to
medicines and apply to all manufacturers, including contract suppliers,
packagers and other third-party entities.
• Foreign Inspections
– In a global marketplace, foreign facilities should be held to
the same standards as domestic plants, including government inspections
at least once every two years and more frequently if FDA detects problems.
Teva supports: 1) taking a risk-based approach that allows FDA to focus
on areas with a higher potential for concerns, 2) charging facility fees
to finance inspection, including additional charges for re-inspection,
and 3) establishing an on-the-ground presence in countries with a large
share of registrations and cited problems
|
 |