We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former Centers for Medicare & Medicaid Administrator Mark McClellan, who said he is optimistic that Congress will pass legislation this year easing the entry of follow-on biologics.
A bill introduced in the Vermont Senate would allow the state to sue drugmakers for what it calls "unconscionable pricing" of prescription drugs used to treat serious public health problems.
The Michigan House of Representatives voted to repeal a state law that prevents residents from suing drug companies — the only law of its kind in the country.
The Centers for Medicare & Medicaid Services (CMS) must strengthen its guidance regarding an exception to Medicaid price-reporting requirements to prevent drug companies’ abuse of that provision, key lawmakers say.
The Democrats’ plan to give the federal government the authority to negotiate for lower Medicare prices has taken another step forward as the House passed H.R.4 by a vote of 255–170.
Just over a year after implementation of the Medicare Part D Drug Benefit, members of Congress are already suggesting changes to the program, the main one being giving the federal government authority to negotiate drug prices with manufacturers. This proposal was a campaign issue during Democrats’ successful effort to take control of Congress and is already one of the hottest items on Capitol Hill. The proposal sailed through the House and now faces an uncertain future in the Senate, as well as a threatened presidential veto. Adding to the changes to Medicare, the Centers for Medicare & Medicaid Services (CMS) is using a proposed rule to test the legality of collecting and sharing prescription drug plan data to base Medicare reimbursements on product comparisons. The CMS also needs a stronger policy to curb a Medicaid pricing ‘loophole,’ according to key senators, who say drug companies are taking advantage of the program. Government healthcare plans are also vulnerable to fraud because few government programs know the actual prices they pay for specific drugs, an academic says. These issues will not go away because of the rise in healthcare spending, which a CMS report predicted will double by 2016. This issue of The Food & Drug Letter looks at these and other developments with Medicare and Medicaid.
A bill introduced in the Vermont Senate would allow the state to sue drugmakers for what it calls “unconscionable pricing” of prescription drugs used to treat serious public health problems.
The Michigan House of Representatives voted to repeal a state law that prevents residents from suing drug companies — the only law of its kind in the country.
The Prescription Access Litigation Project (PAL) has entered a $24 million settlement with EMD Serono and Merck Serono International to resolve a nationwide class-action lawsuit.
Improved drug safety is foremost in the FDA’s Prescription Drug User Fee Act (PDUFA) proposal that seeks new authority and more than $29 million in additional fees specifically to improve its postmarket safety surveillance.