Patent Baristas

Dr. Andrew von Eschenbach, the head of the Food and Drug Administration, addressed the issue of biogenerics at the annual meeting of the annual meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA).  Eschenbach basically outlined that biogenerics would be considered only “similar” to brand-name drugs, not interchangeable or able to be substituted. This […]

Some readers have asked why there is a pediatric exclusivity add-on for FDA approvals. These exclusivity extensions are provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), which permits certain new drug applications to obtain an additional six months […]

Harvard Drug Group has filed an antitrust class action suit against Purdue Pharma alleging an unlawful scheme to maintain its monopoly in the U.S. for its brand name prescription drug OxyContin CR, the notorious opioid analgesic prescribed to treat moderate to severe pain.  OxyContin CR (oxycodone hydrochloride) is a controlled release formulation.  (Harvard Drug Group […]

On March 8, a Senate committee will hold initial hearings on legislation that would establish a process for the U.S. Food and Drug Administration to approve biogenerics (generic versions of biologic drugs known as biosimilars). On average, the FDA approves one new generic version of a conventional (small molecule-type) drug per day but it lacks […]

There is more backlash by generic drug companies against the user fees for generic drug reviews proposed in the 2008 budget. The budget proposal would increase funds for FDA by $100 million, including a large increase in user fees for brand-name pharmaceutical companies and the first fees for generic pharmaceutical companies. The $2.1 billion FDA […]

Representatives Waxman, Emerson, and Pallone, along with Senators Schumer and Clinton, have re-introduced H.R. 1038, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve generic biologics or biopharmaceuticals. While generic drugs have been extremely successful in bringing down the high cost of prescription drugs, […]

Under current law, if a drug company wants to promote a new use of its drug, it can do so by submitting an efficacy supplement to the FDA and getting that use onto the label. Or, the company can rely on off-label prescriptions. While federal law makes it illegal for drug companies to promote drugs […]

Thailand’s Ministry Of Public Health has announced plans to grant a five-year, compulsory license to produce a lower-cost version of Merck’s antiretroviral drug Efavirenz — a move that appears to be legal under the World Trade Organization’s Doha Declaration (an amendment to the WTO’s TRIPS Agreement). Thailand is looking to save on the cost of […]