• Regulatory NewsRegulatory News

    Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency

    At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines. With regard to importation, Rep. Elijah Cummings (D-MD) introduced a bill seeking to allow an increase of less costly medicines from Canada and Sen. Bernie Sanders (D-VT) introduced a similar measure . ...
  • Regulatory NewsRegulatory News

    Trump Working on ‘New System’ to Increase Drug Competition

    President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the current generic drug and biosimilar competitors, remains to be understood. On what such a system might entail, a White House spokesman told Focus : "The President has been steadfast in his commitment to reducing the regulatory burden on everyday Americans. As demonstrated through the ...
  • Regulatory NewsRegulatory News

    Senators Investigate Rising Drug Prices as HHS Plans Action

    The fire stoked by rising drug prices is starting to spread through government, particularly as Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) on Wednesday announced a bipartisan Senate investigation into pharmaceutical price gouging, with letters to four companies. The letters sent Wednesday follow on the heels of HHS announcing Tuesday that it would dig into drug pricing at an invitation-only forum on 20 November. The forum will feature five panel sessions on t...
  • Legislators: Abusive Practices Leading to Drug Shortages, Massive Markups

    • 26 July 2012
    A new investigative report out by a trio of democratic legislators show abusive practices to be rampant in pharmaceutical wholesaling, with re-selling of some drugs contributing heavily to the amount of drug shortages. " Shining Light on the 'Gray Market' ," written by Sen John Rockefeller (D-WV), Sen. Tom Harkin (D-IA) and Rep. Elijiah Cummings (D-MD), comes after hospitals and other healthcare providers had raised concerns about their inability to procure injectable ca...
  • FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages

    The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products. The original report, FDA's Contribution to the Drug Shortage Crisis , claimed FDA had "largely sparked" shortages through its increased reliance on facility inspections and monitoring of regulatory compliance activities....
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...
  • New Bill Hopes to Curb Drug Shortages, Price Gouging

    • 23 May 2012
    A new bill proposed by Rep. Elijiah Cummings aims to curb drug shortages resulting from so-called "gray market" drug sales where companies purchase stock of medicines experiencing shortages and exorbitantly mark up prices to subsequent purchasers. "Nobody should be allowed to engage in profiteering at the expense of children and adults with cancer or other critical illnesses by jacking up the price of drugs that are in critically short supply," said Cummings.  ...