Lisdexamfetamine Dimesylate

More than 330 healthcare organizations signed letters this week urging the White House and Congress to extend a telehealth prescribing flexibility that was introduced during the Covid-19 pandemic. Failure to extend this policy would cause millions of Americans to lose access to “critically important healthcare treatment,” the organizations wrote. In 2020, Congress waived a rule that required an in-person visit to establish a relationship between a patient and their provider before any prescriptions can be given via telehealth. The Drug Enforcement Administration had originally planned to roll back this flexibility last year, but the agency extended it through the end of 2024 after receiving more than 38,000 comments on its proposed rule. presented by Health Tech The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani For nearly four years now, providers have been using the telehealth prescribing flexibility to prescribe controlled substances. These include Schedule II drugs, such as stimulant medications to treat ADHD like Adderall and Vyvanse, as well as opioids like Percocet and Dilaudid. These also include Schedule III-V controlled substances, such as common psychiatric drugs like Xanax, Ambien and Prozac, as well as drugs that treat substance use disorder like buprenorphine. The DEA is still working on a new proposed rule that will dictate whether or not providers can prescribe controlled substances via telehealth after this year — but last week, its plans were leaked by media outlets. The agency’s rule — which is not final and is currently being reviewed at the White House — is definitely not what telehealth advocates were calling for. The rule would get rid of providers’ ability to prescribe Schedule II drugs via telehealth without a prior in-person appointment — either by establishing new regulations or simply allowing the pandemic-era flexibility to expire at the end of the year. On the other hand, Schedule III-V drugs would still be allowed to be prescribed via telehealth without an in-person visit. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Additionally, the unpublished rule would require that no more than half of a provider’s prescriptions may be given via telehealth appointment. It also includes a mandate for prescribers to check all 50 states’ prescription drug monitoring programs before writing a prescription for a patient with whom they have never had an in-person visit. However, enforcing this requirement will be difficult, as providers say there is no national registry where providers could easily check whether or not the patient had obtained a prescription for the drug in another state. Many provider organizations have reacted to the leaked rule with outrage. On Tuesday, more than 300 groups sent separate letters to the White House, Senate and House, imploring them to roll back the strict rules that the DEA is reportedly planning to propose. Some of these organizations included Amazon, Cleveland Clinic, Mass General Brigham, Hims & Hers Health, the American College of Physicians, and the National Rural Health Association. “The ongoing challenges in accessing mental health and substance use treatment services, particularly in rural and underserved areas, underscore the importance of maintaining these flexibilities. More than half of U.S. counties do not have a psychiatrist. The shortage is even more prominent in rural areas, with nearly three quarters of rural counties lacking a psychiatrist,” read the groups’ letter to the White House. Extending the prescribing flexibility would mean that millions of patients in these underserved areas would get to keep their access to treatment, the organizations argued in their letter. The letter also pointed out that there is very little time to make this happen. “Given how late we are in the year and with the waiver expiring on December 31, there is very little time left for the DEA to release a draft rule for public comment, close the comment period, review the substantive feedback, and finalize the rule in time for the end of the year. Nearly 40,000 comments were submitted last year when the DEA first attempted to draft rules for a permanent framework on remote prescribing of controlled substances,” it read.

Astellas' Eccles plant closure and a new R&D center, plus a Chinese investigation into some AstraZeneca staffers made our news this week. Astellas is closing a gene therapy manufacturing facility in South San Francisco. But, across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained several current or former AstraZeneca employees. And more.1. Astellas Gene Therapies to turn out the lights at South San Francisco production plantAstellas’ gene therapy branch is closing its Eccles manufacturing facility in South San Francisco. All existing programs at the plant will be moved to another site in Sanford, North Carolina. While the fate of the California site’s 100 employees wasn’t immediately clear, at least 17 staffers are being let go, according to two public notices.2. Astellas unveils Massachusetts lab that will be shared with biotechs, academia researchersAstellas has opened a new life sciences collaboration hub in Massachusetts. Besides about 400 Astellas employees who will work there, the center includes the Japanese pharma’s first U.S.-based SakuLab, which will be shared with external partners. The location also houses a small-molecule unit focused on targeted protein degradation research.3. AstraZeneca staffers detained in China over patient data collection, drug imports: BloombergFive current and former employees in AstraZeneca’s oncology division have been detained in China, the company confirmed. Bloomberg, citing people familiar with the matter, reports that the investigation centers around a possible violation of data privacy laws and potential illegal importation of an unapproved liver cancer drug. The latest investigation follows an insurance fraud case involving AZ in the country about three years ago.4. Glenmark joins growing list of drugmakers to settle long-running US price-fixing claimsGlenmark has agreed to pay the U.S. Department of Justice $25 million to resolve allegations that it colluded with other drugmakers to rig the price and market around the cholesterol med pravastatin. The payment is separate from $30 million in criminal penalties that the generics maker paid last year as part of a deferred prosecution agreement.5. DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continueAmid an ongoing shortage, the U.S. Drug Enforcement Administration has increased production limits on Takeda’s ADHD drug Vyvanse and lisdexamfetamine generics by 24%. Not all increases are being allocated for U.S. domestic demand. Takeda reported “low inventory” for Vyvanse in June 2023 thanks to increased demand and a manufacturing delay.6. BIOSECURE Act heads for possible vote in House of Representatives next weekThe U.S. House of Representatives has added the BIOSECURE Act to a list of legislation that it plans to consider during the week of Sept. 9. As for the Senate, the most promising path forward would be for it to be folded into the annual defense policy this year. The House version recently added a grace period for biotech companies to cut ties with Chinese service providers.Other News of Note:7. FDA scrutiny of India’s Zydus results in warning letter8. Dr. Reddy's banned from China's drug procurement program after inspectors turn up manufacturing problems9. Allist pays Jacobio $21M for KRAS drug combo, landing leading role in Chinese cancer race10. Takeda taps longtime FleishmanHillard alum to head up global corporate brand and content11. Daiichi study finds gender inequality in European cardiovascular care12. EpimAb licenses BCMA bispecific to Vignette in $635M biobucks deal (release)