• Regulatory NewsRegulatory News

    Consumer Advocacy Group Warns on Orphan Provisions in 'Cures' Act

    Orphan drug provisions in the House-passed 21st Century Cures Act could increase US healthcare spending by billions of dollars over the next decade, consumer advocacy group Public Citizen warns, though the bill still remains in limbo in the Senate. The provisions in question would add an additional six months of marketing exclusivity for approved drugs that later go on to be approved to treat rare diseases. The extended period of exclusivity would apply to all indicati...
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    In Petition to FDA, AbbVie Argues Biosimilars Need Distinctive Labeling

    "Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week. The petition focuses on the labeling requirements for biosimilar products under the 2010 Patient Protection and Affordable Care Act (PPACA) , otherwise known as Obamacare. The law established for the first time an approval pathway—the 351(k) pathway—for biosimilar dr...
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    Group Asks FDA for More Warning Information on Dietary Supplement Labels

    A public health group is calling on the US Food and Drug Administration (FDA) change the warning labels on all herbal and dietary supplements to include more information about how the products might cause side effects, interact with pharmaceuticals and affect pregnant women. Background The call, made in a new Citizen Petition by the group Pharmacists Planning Service (PPS), comes after a recent investigation by the New York Attorney General found that some dietary a...
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    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...
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    Company, Warned by FDA Over Improper Marketing, Petitions Regulators for Redress

    Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation. But one company, cited by FDA in September 2014 Warning Letter alleging that it improperly marketed a product to treat Ebola, is fighting back in an u...
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    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...
  • FDA Says Abuse-Deterrence Equivalence Guidance is Under Development

    The US Food and Drug Administration (FDA) has announced it intends to issue a guidance document regarding the equivalence of abuse-deterrent qualities between generic and branded versions of Purdue Pharma's Oxycontin, laying a pathway to approval for future generic market entrants-and perhaps other types of drugs as well. Background In April 2013, FDA announced that it had determined that an original, non-abuse-deterrent version of Oxycontin (oxycodone hydrochloride) ...
  • FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

    US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...
  • Endo's Aveed Approved by FDA, Drawing Anger from Consumer Group

    US regulatory officials today approved Endo Pharmaceuticals' testosterone replacement therapy drug Aveed (testosterone undecanoate), ignoring a petition submitted last week by a consumer group that claimed the agency should first conclude a safety review of alternative products. Background FDA recently initiated a safety review of testosterone replacement therapy drugs-more commonly known as "Low-T" drugs-after several studies raised concerns about their cardiovascular ...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

    Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products. Background FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies. The studies, in the  Journal of the American...
  • FDA Issues Change to Make it Easier to Submit Citizen Petitions

    It's about to become a lot easier to submit Citizen Petitions to the US Food and Drug Administration (FDA), the agency has announced. The petitions are essentially formal requests made to FDA to take an action-approve a product, declare that a product was not withdrawn from the market for safety reasons, institute a new policy, or even refrain from approving a generic drug product based on potential problems. The wide range of potential uses for the petitions makes them...