Delays in mail delivery may be the latest chink in the U.S. biopharma supply chain. Citing “mounting reports of long wait times for veterans to receive critical prescription medications,” U.S. Reps. Alma Adams (D-N.C.), Peter DeFazio (D-Ore.), Brian Fitzpatrick (R-Pa.) and Mark Takano (D-Calif.) wrote to the postmaster general and the Department of Veteran Affairs (VA) secretary Friday, demanding answers. The letter noted that 80% of VA prescriptions are filled through the mail. In fiscal 2019, the VA’s mail order pharmacy processed 125.2 million outpatient prescriptions. In the past, the lawmakers said, the VA and U.S. Postal Service (USPS) provided speedy service with prescriptions arriving, on average, within three to five days of being ordered. Referencing reports from veterans and VA staff, the lawmakers said those wait times have recently doubled, or tripled in some cases, with medications “allegedly sitting at post office locations for nearly two weeks without movement.” The letter suggested that the delays are due to new leadership and major operational changes being implemented at the USPS. “With local VA healthcare systems around the country experiencing medication shortages and switching to 30-day refills, which could cause additional delays and disruptions given the reliance on USPS, these delays are a real threat to our veterans, and your agencies must do everything possible to rectify the situation,” according to the letter.
Despite the stage 4 restrictions on businesses recently imposed by the state government of Victoria in Australia due to COVID-19, exemptions will apply to suitably licensed warehouses and distribution centers that are part of Australia’s biopharma supply chain, according to the Therapeutic Goods Administration (TGA). Those exemptions will enable medical supply chains to operate at 100% capacity, assisting with the ongoing supply of medicines and medical devices, including personal protective equipment and medical consumables, within Australia, the TGA said.
The FDA finalized its guidance on assessing civil monetary penalties for drug and device applicants who fail to comply with listing requirements in ClinicalTrials.gov. and those who fail to file certification with the FDA or knowingly file a false certification about fulfilling the registry requirements. Certain clinical trials must be registered in the public database, and summary results information for those trials generally must be submitted within one year of the trial’s primary completion date. Applicants who fail to comply can be assessed up to $10,000. If a violation is not corrected within 30 days following notification, the sponsor can be assessed an additional penalty of up to $10,000 for each day the violation continues, according to a notice published in Monday’s Federal Register. “Innovative advances in medical products and transparency in the clinical trials process depend on compliance with ClinicalTrials.gov submission requirements. … As in all areas that we regulate, our goal is to achieve voluntary compliance with the law. However, we intend to hold responsible parties and submitters accountable, including potential legal action, if they are not in compliance,” said Anand Shah, FDA deputy commissioner for medical and scientific affairs.
As part of its preparation for an annual congressional report, the Office of the U.S. Trade Representative is seeking public comment on China’s compliance with the commitments it made when it joined the World Trade Organization in 2001. Topics of interest include China’s practices related to trading rights, import and export regulations, intellectual property rights, transparency, and government policies impacting trade, including subsidies, standards and technical regulations, trade-related investment measures and government procurement practices. The USTR also is asking interested parties to specifically identify unresolved compliance issues that warrant review and evaluation by the office’s China Enforcement Task Force, according to a notice to be published in Tuesday’s Federal Register. Comments should be submitted to Docket Number USTR-2020-0033 by Sept. 16.
Sen. Thom Tillis (R-N.C.) last week urged Andrei Iancu, director of the U.S. Patent and Trademark Office (USPTO), to adopt two proposals outlined by law professors that would optimize inventors’ incentives and reduce unnecessary costs associated with patent prosecution. Tillis had previously sponsored patent reform legislation that failed to gain enough traction for passage in the Senate, although the legislation proposed by Tillis and Sen. Chris Coons (D-Del.) was directed largely to the patent subject matter eligibility question. The first of the reforms Tillis proposed in his letter to Iancu would be to “more clearly distinguish” hypothetical experimental data from data relating to completed experimental/developmental efforts. The second proposal would require patentholders to record transactions involving changes of ownership and to standardize company and individual names so as to reduce confusion encountered in searches for prior art. Tillis said those changes would incur no cost to the taxpayer and only minimal administrative cost to the USPTO while providing modest savings to applicants.