Citing China's dominance in manufacturing active pharmaceutical ingredients (APIs) and generic drugs for the U.S. market, Reps. John Garamendi (D-Calif.) and Vicky Hartzler (R-Mo.) Friday introduced the Pharmaceutical Independence Long-Term Readiness Reform Act, H.R. 4710, to require the Department of Defense to identify the vulnerabilities created by the U.S. dependence on those pharmaceuticals. The bill also would require the Defense Department to only purchase American-made APIs, medicines and vaccines for the military. "Right now, China has the ability to attack the United States without firing a single shot by poisoning our servicemembers' medicines or cutting off their supply," Garamendi said, adding that "China's chokehold on the global pharmaceutical market" leaves the U.S. military and the nation vulnerable to attack. Hartzler called the situation "a grave national security threat," noting that China's "lack of proper oversight and regulatory standards on prescription drugs is also deeply alarming."

The FDA is getting congressional pressure to quickly resolve the recall of Takeda Pharmaceuticals Co. Ltd.'s Natpara, a recombinant human parathyroid hormone used to manage blood calcium levels for people with hypoparathyroidism. The Osaka, Japan-based company recalled the drug Sept. 5 due to a potential issue with rubber particulates from the injector pen contaminating the medicine. As a result of the problem, Natpara has been on the FDA's shortage list since Sept. 11. "Patients across the country have already been hospitalized due to an inability to get Natpara, and we fear that as more patients run out of Natpara, the number of avoidable hospitalizations – or worse – may increase," according to a letter Rep. Peter Welch (D-Vt.) and Sens. Patrick Leahy (D-Vt.) and Bernie Sanders (I-Vt.) sent to the FDA Friday. The lawmakers noted that Takeda worked with the FDA to develop a special use program for Natpara, but the scope of the program appears so small that it will only help about 1% of the patients who need the drug. The Vermont delegation faulted the FDA for not sharing "substantive" information with patients about how long the recall may last or what steps are being taken to develop short- and long-term solutions. "Our constituents have repeatedly contacted FDA and been left confused as to when the drug may become available again, as well as how they should proceed in the meantime. . . . This is entirely unacceptable," the letter said. It urged the FDA "to work with Takeda as expeditiously as possible to resolve the recall, to use the agency's available drug shortage tools to potentially provide patients with other treatment options, and to ensure patients have full information about when the supply of Natpara will resume and what measures patients can take while they wait."

The Biotechnology Innovation Organization (BIO) warned that new foreign investment regulations proposed by the U.S. Department of the Treasury could "damage the vitality of America's thriving life sciences industry by inhibiting investment into U.S. biotechnology companies." In comments on the rules, BIO said the proposal, along with the Committee on Foreign Investment in the United States' (CFIUS) Critical Technology Pilot Program, would expand the transactions subject to CFIUS review beyond what's needed to address national security concerns. "Unnecessarily broad export controls and foreign investment restrictions will damage [the U.S. biopharma innovation] leadership position and only serve to benefit the life sciences industries of other countries," Tom DiLenge, president of BIO's advocacy, law & public policy division, said Monday.

Responding to stakeholder concerns, the EMA's human medicines committee (CHMP) developed a guide to provide more consistency in defining therapeutic indications in the product information for drugs. Intended to help national competent authorities evaluate marketing authorizations and extension-of-indication applications, the guide outlines key elements that assessors should consider, such as whether a drug is a first- or second-line treatment or if it should be used in combination with another product. A drug's indication should clearly state the disease/condition the product is intended to treat and the patient group clearly benefiting from it, the EMA said, noting that doctors need that information to choose the best treatment for their patients. Also, EU health care payers rely on such information when considering a drug's cost-effectiveness, its impact on health care budgets and the seriousness of a disease, the EMA said. CHMP adopted the guide at its October meeting and may develop further guidance on the subject.

In the wake of a recent ruling by the U.S. Court of Appeals for the Federal Circuit, the U.S. Patent and Trademark Office (USPTO) is proposing rules assigning the burden of persuasion in relation to the patentability of proposed substitute claims to the petitioner in an inter partes review and other post-grant proceedings before the Patent Trial and Appeal Board. However, the rules would permit the board to use its discretion in determining the patentability of the proposed claims even when a petitioner doesn't meet its burden, according to a notice to be published in Tuesday's Federal Register. The proposed rules also assign the burden of persuasion in relation to certain statutory and regulatory requirements for a motion to amend to the patent owner, but again permit the board discretion. Comments on the proposed rules are due by Dec. 21.

The USPTO updated its 2019 Revised Patent Subject Matter Eligibility Guidance in response to public comments. "The update provides additional information on how the USPTO determines if a claim 'recites' an abstract idea and how groupings within the abstract idea exception are determined," the USPTO said. It also explains procedures examiners use to identify "tentative abstract ideas" and addresses the examiner's responsibility to adequately notify applicants when rejecting an application based on subject matter eligibility. The update includes additional examples in the life sciences area, as well as an updated case law chart that lists selected eligibility cases from the U.S. Supreme Court and the Federal Circuit.

The FDA issued a draft guidance revising its 1989 guidelines on drug master files (DMFs), which are voluntary submissions that may be used to provide confidential, detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of biopharmaceuticals. The draft provides information about preparing and submitting DMFs, and describes DMF types, the information needed in submissions and the FDA's DMF review processes. The update includes new procedures for DMFs referenced in abbreviated new drug applications that reflect commitments under GDUFA, more detailed instructions regarding the submission of original DMFs vs. amendments and a reference to the electronic submission requirements. It also removes type I as a DMF category and clarifies and reorganizes material associated with type III and IV DMFs. Comments on the draft are due by Dec. 20.

The FDA released final guidance Friday to help sponsors develop systemic drugs for HIV-1 pre-exposure prophylaxis (PrEP). The guidance provides nonclinical and clinical recommendations, with a focus on long-acting systemic drugs intended to prevent sexually acquired infections. Investigational drugs for further development as PrEP include oral drugs already approved to treat HIV-1 infections, oral HIV-1 drugs that are reformulated as long-acting products or other delivery systems for PrEP, and new investigational drugs.

The U.S. SEC is asking listing exchanges to submit innovative proposals for changes in the equity market structure designed to improve trading in thinly traded securities. "The current equity market structure generally works well for securities that trade in higher volume," the SEC said, but it is concerned that the current "one-size-fits-all" structure, largely governed under Regulation NMS, may not be optimal for securities traded at lower volumes. Thinly traded securities face "liquidity challenges that can have a negative effect on both investors and issuers," the commission acknowledged.

The U.S. District Court for the District of Maryland entered a final judgment last week against Bobby Dwayne Montgomery, the former chief business officer of Osiris Therapeutics Inc., for his role in overstating the company's performance and issuing fraudulent financial statements for two years. In bringing the charges against Montgomery, the SEC said he caused Osiris to book fictitious revenue and provided false information to the company's auditors. Montgomery consented to the judgment, which ordered him to pay a civil penalty of $40,000. Osiris previously paid a $1.5 million penalty in a related SEC settlement. The SEC said it is continuing litigation against former Osiris CEO Lode Debrabandere and former CFO Philip Jacoby. The Columbia, Md.-based company became part of Smith & Nephew plc this year in a $660 million cash deal. (See BioWorld, March 13, 2019.)