Those who have been reading this blog know that I like to analyze collections of documents at FDA to discern, using natural language processing, whether, for example, the agency takes more time to address certain topics than...more
This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions. Make no mistake, I have an interest in this...more
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics...more
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral...more
The Orphan Drug Act provides two mechanisms by which a drug can receive an orphan drug designation for a “rare” disease: (1) if it affects less than 200,000 persons in the United States, or (2) if it “affects more than...more
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more
The Federal Trade Commission (FTC) submitted comments supporting the Food and Drug Administration’s (FDA) guidance for assessing whether a pharmaceutical company petitioner is misusing the citizen petition process to delay...more
The FDA has recently thrown its hat into the debate between brand and generic drug manufacturers about the proper way to compete. Generics often accuse brands of improperly trying to extend their monopolies over patented...more
On August 22, 2018, Pfizer submitted a citizen petition to the Food and Drug Administration requesting “guidance clarifying appropriate sponsor communications about the nature and properties of biosimilar products.” ...more
In a novel interpretation of the Federal Trade Commission (FTC) Act, the U.S. District Court for the District of Delaware recently held in FTC v. Shire ViroPharma that the FTC had failed to plead the facts necessary to invoke...more
Brand-name pharmaceutical companies employ a variety of strategies to preserve and extend their branded drug products’ monopolies. Challenges by generic drug manufacturers and consumers to those efforts as allegedly...more
The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn consumers about alleged birth defect risks when the FDA had previously rejected a...more
We previously reported that Apotex filed a Citizen’s Petition requesting that FDA require biosimilar applicants to conduct comparative clinical efficacy studies in at least one intended patient population, rather than...more
Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that...more
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more
FDA has denied AbbVie’s Citizen Petition on interchangeability. Back in December 2015, AbbVie submitted a Citizen Petition to FDA requesting that the agency take certain actions regarding interchangeability standards for...more
Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more
About 12 months ago, AbbVie filed a Citizen Petition asking the FDA to take certain steps to tighten and clarify its procedures for making interchangeability determinations. Earlier this year, both Sandoz and GPhA urged the...more
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more
FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations...more
As we previously reported, late last year the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Industry Organization (BIO) trade associations jointly submitted a Citizen Petition asking the FDA...more
As we previously reported, in late 2015, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations jointly submitted a Citizen Petition asking the...more
As we previously reported, UAW Retiree Medical Benefits Trust and affiliated funds filed a Citizen Petition on November 2, 2015 asking FDA to adopt a “same labeling” approach for biosimilar labeling. On May 19, 2016, FDA...more
In 2015, FDA issued a number of final guidance documents for biosimilars. But many fundamental questions remain unsettled and the industry awaits FDA’s guidance on labeling of biosimilars, the requirements for...more
AbbVie, Inc., a biopharmaceutical company, has submitted a citizen petition to the FDA regarding determinations of interchangeability under the BPCIA. An interchangeable biological product is biosimilar to a reference...more