Warning against reimportation, FDA says drugs made for foreign markets could contain different active and inactive ingredients, which could affect the bioavailability of the drug.

The Canadian International Pharmacy Association (CIPA) has laid out guidelines for Americans seeking reputable Canadian pharmacies from which to buy their drugs.

Medco Health Solutions’ $29 million payout to settle state fraud allegations will intensify state efforts to regulate pharmacy benefit managers (PBMs), sources close to the issue predict.

Standardized electronic prescribing of Part D prescriptions could be achieved two years ahead of the compliance deadline set by Congress, according to CMS chief Mark McClellan.

FDA is developing an action plan that could lead to regulatory controls or, at a minimum, new studies on a suspected carcinogen the agency recently discovered inadvertently in a variety of canned and jarred foods.

An FDA drug safety advisory committee is wary of having FDA relax the risk management plan for the irritable bowel syndrome (IBS) drug Lotronex despite complaints from GlaxoSmithKline that the plan is too cumbersome. Committee members said the Lotronex risk management plan is supposed to be restrictive, and is no more onerous than other risk management plans.

The Senate Finance Committee is investigating if Medicaid is being overcharged for prescription drugs because pharmaceutical companies are violating congressional intent in their use of a Medicaid pricing exemption.

Attorneys general of 20 states are urging HHS Secretary Tommy Thompson to allow prescription drug importation under the newly enacted Medicare law.

Canadian Internet pharmacies are open to FDA oversight, but FDA has rebuffed their multiple invitations to be inspected, according to David MacKay, executive director of the Canadian International Pharmacy Association (CIPA).

Canada’s parliament is set to approve a potentially precedent-setting bill that will place limitations on the profits generic drug manufacturers can earn and the prices they can charge on pharmaceuticals produced under a compulsory license for export to developing countries.

Frustrated by the state's inability to stop drug companies from blocking sales to Canadian pharmacies that sell to U.S. consumers, Minnesota is now considering reimporting drugs from Europe.

The HHS Office of Inspector General (OIG) has found Medicare overpays for drugs provided in dialysis facilities, but the margins vary greatly between smaller facilities and larger chains, especially for erythropoietin (EPO), which accounts for the lion’s share of drug costs.

A study released by CMS yesterday (May 5) found that seniors can save as much as 17 percent for a typical monthly drug bill by using a Medicare discount drug card, compared to average national prices paid at the retail level.

FDA has issued a proposed rule that defines a combination product’s primary mode of action as the “single most important therapeutic action” of the product.

FDA will release a white paper on food good manufacturing practices (GMPs) following three public stakeholder meetings to be held this summer, acting FDA chief Lester Crawford said Thursday (May 6).

Democrats are reviving calls for a congressional probe into the Bush administration’s censorship of its Medicare cost estimates after a non-partisan branch of Congress said senior administration officials appear to have broken the law by muzzling CMS’ chief actuary during last year’s Medicare debate.

A significant new Environmental Protection Agency rule calling for skin absorption testing on a record number of toxic chemicals could lead OSHA to recommend that chemical manufacturers take steps to prevent potential adverse health effects to workers.

The House Ways and Means Committee's call for an administrative tweak to the Medicare physician payment formula would have no short-term impact on years of projected cuts in reimbursements, but would lower the cost of a legislative fix that would be needed to avoid a 5 percent cut in 2006.

The over-the-counter drug industry group is urging FDA to shift primary responsibility for Rx-to-OTC switches from the agency’s prescription drug review divisions to the OTC division. The group says transferring responsibility will help speed the switch process.

HHS Secretary Tommy Thompson has rejected a proposal by Senate Democrats to allow new Medicare drug discount card enrollees 30 days to switch cards.