Drugs
Attorneys Rachel Hunt and JP Ellison (Hyman, Phelps & McNamara) cite a Pennsylvania federal court decision as further proof that courts have been narrowing situations in which they will find liability under the False Claims Act (FCA) due to a Supreme Court decision in United Health Services v. United States
Drugs
Staffers in the CDER Office of Hematology and Oncology Products say that of more than 250 new drug and biologic applications approved by the office since 2006, only one was approved for use with radiation. Writing in an International Journal of Radiation Oncology commentary (subscription or purchase required), the staffers
Drugs
FDA has determined that Amgen’s erythropoiesis-stimulating agents (ESAs) epoetin alfa (Procrit and Epogen) and darbepoetin alfa (Aranesp) no longer require a Risk Evaluation and Mitigation Strategy (REMS). The REMS, which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated
Drugs
Purdue Pharma has resubmitted its 3/27 petition asking FDA to place specific restrictions on follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug. The company says the requirements are necessary to ensure that any follow-on products are as safe and
Drugs
President Trump has lifted his January-ordered hiring freeze (see earlier story) affecting FDA and other agencies, and instead he has ordered agencies to take immediate actions to reduce staff and cut costs in line with his recent fiscal year (FY) 2018 Budget Blueprint. An Office of Management and Budget
Drugs
FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements of the jaw, lips and tongue. The disorder is a serious side effect associated with patients who have been treated with antipsychotic medications, especially the
Drugs
The World Health Organization (WHO) says it is working with finished pharmaceutical product manufacturers to identify additional sources for levonorgestrel following an FDA 3/8 import alert on Qinhuangdao Zizhu Pharmaceutical in Hebei, China. In its response to the import alert, WHO says that FDA investigators found failures in the
Drugs
Attorney Anne Walsh (Hyman, Phelps & McNamara) says the Department of Justice (DoJ) enforced FDA current good manufacturing practice (cGMP) regulations through a 1/12 False Claims Act (FCA) global settlement with Baxter Healthcare. In a Washington Legal Foundation Counsel’s Advisory, she raises the question of whether it is
Drugs
Reps. David McKinley (R-WV) and Peter Welch (D-VT) have introduced the Fair Access for Safe and Timely (FAST) Generics Act to “thwart manipulation of FDA’s drug safety regulations in order to block the production of generic alternatives to brand name medicines.” The two say the bill would
Drugs
A 9/5-9/14/16 FDA inspection at Mylan Laboratories, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/3 Warning Letter. Specific violations included: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Drugs
Three McCullough Robertson attorneys say that “sparse” provisions of the Biologics Price Competition and Innovation Act’s (BPCIA) default protective order addressing issues of prosecution and regulatory bars “leave ample room for the parties to set the scope of the pre-litigation protective agreement and the protective order in effect
Drugs
An 8/31-9/4/16 FDA inspection at Indoco Remedies, Goa, India found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/27 Warning Letter. Specific violations included: * failing to establish and follow adequate written procedures describing the handling of all written
Drugs
A Public Citizen survey finds few major drug company CEOs willing to commit to limiting drug price increases. The group says in a report that only AbbVie, Novo Nordisk, and Valeant were willing to match an Allegan 9/6/16 blog post committing to restricting annual price increases of their
Drugs
Attorney David Fox (Hogan Lovells) told an AtlanticLIVE biosimilars policy briefing that while progress in the biosimilars market “may seem glacial, by lawyer and FDA standards this market is actually moving at the appropriate pace.” In an online post, Biosimilar Development says that the briefing demonstrated through its presentations that
Drugs
Isomeric Pharmacy Solutions has recalled all lots of sterile products compounded and packaged that remain within expiry to the hospital/user level due to FDA concerns about a lack of sterility assurance after it recently inspected the firm. Affected products were distributed to patients, providers, hospitals, or clinics nationwide between10/
Drugs
FDA in a meeting with Repros Therapeutics has told the company that a partial clinical hold will continue against Proellex (telapristone acetate) and its use in treating uterine fibroids while they consult with liver experts within the agency regarding previously disclosed effects on the liver. “Further, the FDA agreed to
Drugs
Will President Trump’s “America First’ mantra lead to a resurgence in pharmaceutical manufacturing investments in the U.S.? That is the hope of some FDA watchers writing in a Morning Consult op-ed that offers advice on how to spur innovation in domestic manufacturing that could lead to potentially
Drugs
Rep. Morgan Griffith (R-VA) has introduced H.R. 2025, the “Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017, a bill to prevent certain drug applications from being considered ineligible for approval on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be
Drugs
FDA has issued Merck a complete response letter on supplemental NDAs for Januvia (sitagliptin), Janumet (sitagliptin and metformin HCl) and Janumet XR (sitagliptin and metformin HCl extended-release). In these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of
Drugs
FDA should refrain from approving a generic copy of United Therapeutic Corp.’s Tyvasco (treprosrinil) if it determines that the proposed generic device and components differ in critical design attributes or if the generic delivery system would require patients to be retrained in use of the device, according to a
Drugs
FDA has released a guidance on “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically. It also implements the electronic submission requirements outlined
Drugs
FDA has approved two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Previously, the therapies were approved to treat HCV in adults. According to an FDA news release, Harvoni is indicated for treating pediatric