Pharmaceuticals

Section 7058(c)(2) allows up to $200,000,000 for combating infectious disease outbreaks, which would directly benefit pharmaceutical companies through funding for vaccines, treatments, and medical countermeasures. Additionally, Section 7058(c)(3) references the Emergency Reserve Fund which could be used for pharmaceuticals and other products for child survival, malaria, and tuberculosis.

Section 2 expands the exclusion for orphan drugs under the Drug Price Negotiation Program by allowing time during which a drug was designated for multiple rare diseases to not count toward the negotiation eligibility period, thereby extending market exclusivity and delaying price negotiations, which benefits pharmaceutical manufacturers.

Section 2(b) establishes liability for sham citizen petitions that interfere with approval of competing generic drugs or biosimilars, which benefits generic drug manufacturers by deterring anti-competitive delays. Section 2(c)(4) allows civil penalties based on revenue from the drug product referenced in the sham petition, directly impacting branded pharmaceutical companies that file such petitions.

Section 2(a) amends PHSA to include financial assistance from prescription drug manufacturers toward cost-sharing requirements, effectively allowing such assistance to count toward deductibles, coinsurance, copayments, and out-of-pocket limits, which benefits pharmaceutical manufacturers by increasing affordability and uptake of their drugs.

Section 2 authorizes VA health care professionals to deliver, distribute, or dispense controlled substances via telemedicine, which expands the market for prescription drugs and benefits pharmaceutical manufacturers.

Section 2(a)(3) adds subparagraph (E) to eliminate VA medication copayments for preventive health services, increasing demand for medicines provided by pharmaceutical manufacturers.

Section 2209 extends temporary inclusion of authorized oral antiviral drugs as covered Part D drugs, directly benefiting pharmaceutical manufacturers by maintaining drug coverage under Medicare Part D.

Section 2(a) directs the Coast Guard to update policy regarding use of medication to treat drug overdoses, including naloxone or similar medication, which would increase demand for such pharmaceuticals.

Section 209 reviews scheduling of buprenorphine/naloxone products, potentially facilitating access to medication-assisted treatment; Section 210 ensures references to opioid overdose reversal agents in HHS grant programs are inclusive of any FDA-approved drug, expanding market for naloxone and similar products.

Section 2(a) creates an exception to the physician self-referral prohibition for certain outpatient prescription drugs furnished by a physician practice under Medicare, which would allow physicians to dispense Part D drugs directly, increasing demand for pharmaceuticals and benefiting manufacturers.

Section 3 creates an alternative registration process for Schedule I research, including expedited procedures for practitioners conducting research with fentanyl-related substances, which benefits pharmaceutical and biotech companies engaged in opioid research and development.

Section 2(a)(1)(A) requires replacing references to 'animal' tests with 'nonclinical' tests in FDA regulations, which benefits pharmaceutical companies by allowing alternative testing methods that may reduce costs and accelerate drug development.

Section 2(a)(3)(d)(1) requires the Secretary of Veterans Affairs to include certain non-opioid pain management drugs or biological products in the national formulary, which will increase demand for such medications, benefiting pharmaceutical manufacturers.

Section 1(a) directs the Secretary of Veterans Affairs to furnish an opioid antagonist (e.g., naloxone) to veterans without requiring a prescription, which expands market access for opioid antagonist manufacturers, a subset of the pharmaceuticals industry.

Section 3(a)(2)(A) states the Center of Excellence will advance biopharmaceutical manufacturing, including developing flexible technologies and improving processes for multiple biopharmaceutical manufacturing platforms, which directly benefits pharmaceutical manufacturers involved in biopharmaceutical production.

Section 3(b)(1)(A)(ii) adds oral health services for pregnant and postpartum women to Medicaid coverage, which includes diagnostic, periodontal, and restorative care. This expands dental services that may involve pharmaceuticals (e.g., antibiotics, analgesics) used in dental treatment, benefiting pharmaceutical manufacturers.

Section 2(b)(2) requires the Secretary to furnish pharmaceutical products delivered by mail to veterans in the Freely Associated States, increasing demand for pharmaceutical products.

Section 2(b) specifies over-the-counter antihistamines, acetaminophen, NSAIDs, antiseptics, zinc oxide, antibiotic ointments, and wound care supplies as required Medicaid coverage, directly benefiting pharmaceutical manufacturers of these products.

Section 2(a) provides Medicare coverage for non-self-administrable home infusion drugs, benefiting pharmaceutical manufacturers that produce these drugs.

Section 2(b)(4) applies to manufacturers of investigational drugs, including pharmaceutical companies, requiring them to share interim clinical trial data, which supports drug development and regulatory processes for ALS therapies.

Section 5(b)(1)(B)(ii) requires Medicare Advantage organizations to apply coverage criteria for long-term care hospital services that are not more restrictive than standards under Part A/B, including section 1861(ccc) which covers certain inpatient hospital services, potentially increasing access to pharmaceuticals administered in those settings.

Title II funds NIH ($2.3B for NIDDK, $2.86B for NINDS, etc.) and CDC vaccine programs, supporting pharmaceutical R&D; Sec. 237 rescinds $2B from Nonrecurring Expenses Fund but overall funding levels remain high for drug development.

Section 205 allows importation of prescription drugs from Canada for personal use, increasing market access for pharmaceutical manufacturers selling in Canada.

Section 4(a)(1) requires the USPTO Director to consult with the FDA Commissioner regarding patents for human drugs and biological products, facilitating information sharing that could streamline patent examination and benefit pharmaceutical companies.

The bill includes biomanufacturing and product commercialization activities that would benefit pharmaceutical companies producing biologics, vaccines, and other biotechnology-derived drugs (Sections 3(c)(5), 4(b)(3)(E), 5, 6(5)). The initiative supports translation and scale-up of biotechnology products, directly aiding pharmaceutical innovation and manufacturing.

Section 2(a)(2) prohibits federal agencies from restricting prescription or disbursement for unapproved use of any FDA-approved drug, expanding off-label use and benefiting pharmaceutical manufacturers.

Section 10 requires CMS to report on coverage of remote physiologic monitoring devices (e.g., blood glucose monitors) under Medicaid, which could increase utilization and reimbursement for pharmaceutical/device manufacturers producing such monitoring tools.

Section 3(a)(1)-(2) requires pharmacies to provide FDA-approved contraceptives and related medications without delay, increasing demand for these products and benefiting pharmaceutical manufacturers.

Section 2(e)(1)(B)(i) requires hospitals to disclose standard charges including National Drug Code identifiers for drugs, increasing transparency that benefits pharmaceutical manufacturers by enabling price comparison and potentially driving competition; Section 3(f)(2)(A) similarly requires clinical labs to disclose NDC codes for drugs in tests, further aiding pharmaceutical price transparency.

Title VI, Defense Health Program includes $1,921,212,000 for research, development, test and evaluation, with not less than $897,000,000 for congressionally directed medical research programs, which benefits pharmaceutical companies through drug development funding.

Title II includes funding for the National Institutes of Health (NIH) which supports pharmaceutical research and development, e.g., National Cancer Institute ($7,374,159,000), National Institute of Allergy and Infectious Diseases ($6,592,279,000), and other institutes that fund drug discovery and vaccine development, directly benefiting pharmaceutical companies.

Section 2102 extends Special Diabetes Programs for Type I Diabetes and for Indians, providing funding for diabetes treatments and medications, which benefits pharmaceutical manufacturers.