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The Latest in Regulatory and Reimbursement
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Biocom California has responded to the White House’s recent Request for Information on the biotechnology and biomanufacturing initiative. The FDA has released a report highlighting last year’s novel drug approvals, CDER and CBER are resuming some in-person face-to-face meetings, and a final rule has been published with updates to radiological health regulations. CMS has announced key dates for the first year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act and the agency has engaged stakeholders to provide more feedback on its Discarded Drug Refund Policy.
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Biocom California Responds to White House Request for Information
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CDER’s 2022 Novel Drug Approvals
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A recent FDA report highlights CDER’s approval of 37 novel drugs with 20 of those approved to treat rare or orphan diseases. Last year, the agency also approved its 40th biosimilar and two interchangeable biosimilar products. |
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FDA to Resume Some In-Person Meetings
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Effective February 13, CDER and CBER will resume in-person face-to-face industry meetings (with a hybrid component) for Type A, biosimilar biological product development (BPD) Type 1, and Type X meeting requests. |
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FDA Publishes Radiological Health Final Rule
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The final rule, effective February 21, amends and repeals outdated and duplicative radiological health recommendations. Updates were made to radiation protection, records and reporting, and performance standards for certain products.
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CMS Hosts Town Hall on Discarded Drug Refund Policy
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The town hall discussed policy specifics that will determine the charges that manufacturers must refund to the agency based on the total discarded drug amount. Biocom California commented on the policy in the CY 2023 Physician Fee Schedule rule. |
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Key Dates Announced for IRA Drug Pricing Negotiation Program
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Key dates for the 1st year of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act (IRA) include: By September 1, 2023, the program’s first 10 Medicare Part D drugs will be published, their negotiated prices will be announced by September 1, 2024, and pricing will go into effect starting January 1, 2026.
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Request for Comments
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Biocom California welcomes feedback from members on the following proposed rules. Click here to submit comments via email.
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- The proposed annual FDA DSUR regulation would require sponsors with an IND to provide an annual report that is more comprehensive and informative of risks than the current annual report.
- This proposed rule would increase international harmonization between the FDA and global regulatory authorities since the proposed DSUR would be consistent with the format and content recognized by the International Council for Harmonisation.
This guidance may be of interest to drug manufacturers.
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- Build and maintain a system to automate the prior authorization requests, decisions, and required documentation process.
- Include a specific reason when a prior authorization request is denied.
- Send prior authorization decisions within specific timeframes for urgent and standard requests.
- Publicly report certain prior authorization metrics on an annual basis.
This guidance may be of interest to medical device manufacturers.
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Upcoming Regulatory and Reimbursement Events:
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Featured Members
In December 2022, the FDA granted the first gene therapy approval for the treatment of high-risk, non-muscle-invasive bladder cancer to Ferring Pharmaceuticals.
Mirati Therapeutics was granted FDA accelerated approval for its drug, Krazati, for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer.
The FDA granted approval to Gilead Sciences for Sunleca, a new antiretroviral medication for adult patients living with HIV-1.
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Biocom California
For over 27 years, Biocom California has helped move the life science industry forward with transformative resources that enable companies to make meaningful connections. With a membership base of over 1,700 companies, we connect our members to each other so they can collaborate and work stronger and smarter together. We connect organizations to capital investment and purchasing solutions so they can grow faster and work more efficiently. We’re their link to advocacy that fights for innovation and we provide an environment where their business and talent can thrive. Biocom California is how the life science industry gets connected.
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