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Pharmaceutical manufacturers reiterated their opposition to drug reimportation last week at the second public meeting of the HHS Task Force on Drug Importation, maintaining their contention that it is impossible to ensure that imported drugs are safe and effective.
During the next two years, the implementation of the Medicare Prescription Drug, Improvement and Modernization Act will have a greater impact on drugmakers than the drug-review process at the FDA, according to the top lawyer at HHS.
Representatives of the drug industry pounded the HHS Task Force on Drug Importation yesterday with their contention that it is impossible to ensure that imported drugs are safe and effective.
The Centers for Medicare & Medicaid Services (CMS) is currently weighing decisions regarding a $500 million Medicare replacement drug demonstration project that could have significant consequences on the demand for different drug-administration forms.
U.S. Surgeon General Richard Carmona said yesterday he believed there would be significant challenges to safely importing drugs from other countries into the U.S., even though the HHS task force he chairs still has meetings scheduled to hear evidence on the issue.
The Centers for Medicare & Medicaid Services’ (CMS) long-awaited interim final rule on drugmakers’ submissions of average sales price (ASP) data does little to flesh out the generalities of the Medicare Prescription Drug, Improvement and Modernization Act regarding how to calculate ASP, but high-ranking company officials are still required to certify the accuracy of the data.
The Maryland Senate has passed a bill that would require the state Health and Mental Hygiene Department to develop a mail-order plan for importing prescription drugs from Canada.
The chairman of the Senate Finance Committee has ramped up his investigation into allegations the FDA withheld -- and continues to withhold -- a report that says there may be increased risk of suicide among children taking antidepressant medications, and demanded the agency provide records and make officials available for interviews.
The HHS Task Force on Drug Reimportation convened its first public meeting earlier this month, at which PhRMA found itself in agreement with consumer advocates on one key topic: the push to get the FDA to publish a final rule on paper pedigrees.
Although HHS appears to be on track to kick off the discount drug card program within the ambitious timeframe mandated by the new Medicare law, pharmaceutical manufacturers are still unsure exactly how the plan will affect their bottom lines or patient assistance programs they already have in place.