• Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

    A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape. The Stop Tampering of Prescription Pills Act of 2012 , introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]." Such a product ...
  • Supreme Court Rules Company Can Sue Novo Nordisk For Delaying Generic Medication

    • 18 April 2012
    The Supreme Court of the United States ruled 17 April that Caraco Pharmaceuticals can proceed with a lawsuit against Novo Nordisk over Nordisk's purported attempts to prevent Caraco's generic entry into the market, reports various news sources. "At issue was the ability of a brand-name drugmaker to block generic competition by providing the US Food and Drug Administration (FDA) with overly broad descriptions of its patents," writes  Pharmalot . Caraco's lawsuit a...
  • Study Calls for Changes to FDA Treatment of Generic Competition

    Researchers have published a new study in the medical journal Archives of Internal Medicine , in which the researchers argue consumers are being short-changed by US Food and Drug Administration (FDA) regulations that promote excessive reformulations and stymie generic substitution, reports various sources. To illustrate their point, the authors, led by Dr. Harlan Krumholz of Yale University, studied the effect of reformulations on pharmaceutical manufacturer Abbott Lab...
  • Report: Clashes Between White House, FDA Frequent

    A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies. The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services S...
  • Lawsuit Seeks to Overturn Sebelius' Decision, Allow Wider 'Morning-After-Pill' Access

    A coalition led by the Center for Reproductive Rights (CRR) on 8 February sought to overturn a decision made by US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius. The group appeared before Judge Edward Korman of the US District Court in Brooklyn, NY, to petition the court to re-open a lawsuit that would allow those under the age of 17 to access the "morning-after-pill" levonorgestrel without a doctor's prescription. While the US Food and Dru...
  • Hamburg Discusses Plan B Decision, Lawsuit Against Agency

    • 07 February 2012
    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg gave a lengthy interview to Forum host Michael Krasney on a number of controversial topics during a 6 February interview, including a recent whistleblower lawsuit and the FDA's overruled decision regarding Plan B One-Step. Hamburg discussed the controversial Plan B One-Step decision made last month by the agency. FDA had determined that the pill, used to prevent pregnancy by preventing ovulation or f...
  • OIG Report on Part B Pricing Shows Widespread Violations, Notes Payment Methodology Changes

    The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) released a report on 3 January that highlights widespread violations in the reimbursement of pharmaceutical products purchased by the Medicare Part B program. The audit revealed widespread failure to submit complete-or sometimes any-data for approximately 24% of all product codes and 34% of all products. Medicare Part B is a program that administers medical insurance to US citi...
  • Pendergast, Pitts: Sebelius' Decision on Plan B Political, Step Down a 'Slippery Slope'

    Mary Pendergast, former US Food and Drug Administration (FDA) Deputy Commissioner under President Clinton, and Peter Pitts, the former FDA Associate Commissioner under President George W. Bush, offered scathing critiques of Secretary of Health and Human Services Secretary Kathleen Sebelius during an interview on 1 January 2012. Appearing on WUSA9's BioCenturyTV , Pendergast called the recent decision by Sebelius to overrule the FDA's decision in favor of less restrictiv...