The Honorable Lamar Alexander
Senate Health, Education, Labor, and Pensions Committee
455 Dirksen Senate Office Building
Washington, DC 20510
The Honorable Patty Murray
Senate Health, Education, Labor, and Pensions Committee
154 Russell Senate Office Building
Washington, DC 20510
Dear Chairman Alexander and Ranking Member Murray,
ASHP appreciates the opportunity to submit comments to the United States Senate Committee on Health, Education, Labor and Pensions on the Lower Health Care Costs Act of 2019.
ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 50,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
We applaud the Committee's efforts to address drug pricing. ASHP’s vision is that medication use will be optimal, safe, and effective for all people all of the time. A primary tenet of that vision includes access to affordable medications needed to save or sustain lives. Addressing the issue of skyrocketing drug prices, including excessive price increases on commonly used generic medications, is one of ASHP’s highest and longstanding public policy priorities.
ASHP has been proactively addressing challenges related to the rapid increase of prescription drug prices on several fronts, including working with like-minded stakeholders and educating members of Congress about the unsustainable burdens faced by patients, healthcare providers, and the entire healthcare system.
We are pleased that the Committee is taking steps to, increase transparency in drug prices, and improve public health. ASHP respectfully submits the following comments to the Committee's draft legislation:
ASHP Supports the Following Sections Addressing Rising Drug Prices:
Sec. 202 Orange Book Modernization
Sec. 203 Ensuring Timely Access to Generics
Sec. 205 Preventing Blocking of Generic Drugs
Sec. 208 Clarifying the Meaning of New Chemical Entity
Sec. 209 Streamlining the Transition of Biological Products
ASHP believes there are opportunities to strengthen the language in the following sections:
- Sec. 201 Biological Product Patent Transparency
ASHP supports Congress’ efforts to increase transparency of patent information for biological products and was pleased that your colleagues in the House recently passed the Purple Book Continuity Act of 2019 (H.R. 1520). This provision requires the Secretary to publish a list of any holders of biological product licenses that failed to submit certain patent information. ASHP recommends that Congress include meaningful consequences for noncompliance, rather than only a notification of those who fail to submit the necessary information. Absent a significant penalty, producing a list of noncompliant manufacturers is unlikely to change their behavior.
- Sec. 204 Protecting Access to Biological Products
To further improve access to low-cost biologics, ASHP believes the Committee should include language in Section 204 that requires shared nonproprietary naming for biologics and biosimilars. We are concerned that FDA’s biosimilars naming framework deviates unnecessarily from the naming paradigm applied to small-molecule drugs and generics. These suffixes may confuse clinicians and complicate postmarket surveillance. Specifically, because four-consonant, non-meaningful, unpronounceable suffixes are unlikely to be readily recalled or associated accurately with specific products, names with these suffixes may complicate FDA’s goals of product recognition and recall by prescribers and patients.
Moving away from shared nonproprietary naming may also adversely impact postmarketing surveillance.
Finally, implementing the new naming framework will be extremely expensive and onerous. This change will require every segment of healthcare, including but not limited to, hospitals, payers, and providers, to engage in thousands of hours of information technology redesign and reprogramming.
- Sec. 206 Education on Biological Products
ASHP appreciates the Committee’s recognition of the need to provide educational materials to healthcare providers about biological products. We request that the Committee include pharmacists in the list of providers. We also encourage the Committee to provide resources beyond an internet website for such materials. Educational materials should incorporate principles of adult learning and utilize multiple channels, including in-person educational meetings, print and digital learning tools, journal articles, etc. FDA should be encouraged to request assistance from provider associations, such as ASHP, who are engaged in the education of clinicians.
- Sec. 207 Biological Product Innovation
We respectfully request that the Committee delete Section 207 – removing a Public Health Service Act requirement that biologic products adhere to United States Pharmacopeia (USP) public quality standards -- from this draft proposal. Although the proposal intends to lower drug costs by accelerating the development of biologic medicines, including biosimilars, we are not aware of any evidence that USP standards delay or hinder the development or approval of biologics or biosimilars.
The quality benchmarks in a USP public standard allow for an independent determination that a product has been made according to quality expectations regardless of the manufacturer or manufacturing process. These standards are used by many entities to test for quality, at any point along the supply chain. As such, USP’s public quality standards foster trust in the quality of biologics for the practitioners who prescribe, dispense, and administer them, as well as trust from the patients who benefit from them. The absence of the USP's public standards would undermine public trust and impair quality inspections in both U.S. and overseas facilities.
- Sec. 306 Health Plan Oversight of Pharmacy Benefit Manager Services
ASHP has long been a supporter of greater transparency in drug pricing, including improved oversight of pharmaceutical benefit manager payment arrangements with plans and manufacturers. Specifically, rebates on drugs should be disclosed to participants in the system, including both patients and plan sponsors, at the point of sale.
We also request that the Committee study the negative impact that direct and indirect remuneration (DIR) fees or other similar fees have on patient care.
Additional Opportunities to Strengthen the Draft Legislation
ASHP believes including additional language incentivizing generic competition and curtailing practices that reduce the entry of competitor drugs into the marketplace will strengthen the draft.
In particular, ASHP would like to see language that eliminates many of the barriers to generic competition. ASHP recommends the Committee include in the draft: the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, the Protecting Consumer Access to Generic Drugs Act, the Fair Accountability and Innovative Research (FAIR) Drug Pricing Act, and the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.
The CREATES Act requires branded drug companies to provide samples of their drugs to generic manufacturers. The FAIR Drug Pricing Act requires drug manufacturers to report publicly and provide justification for any pending price increases for certain drugs provided to Medicare and Medicaid beneficiaries 30 days before the increase. The Protecting Consumer Access to Generic Drugs Act makes illegal the practice of pay-for-delay, and the REMEDY Act addresses evergreening, the practice of branded drug companies delaying the introduction of generics by manipulating the patent system to create barriers to competition.
The legislation referenced above addresses the unfair tactics branded drug companies use that severely limit the ability of generic manufacturers to enter the marketplace. Incorporating the bills referenced above would be an essential step toward increasing patient access to affordable drugs.
Again, we appreciate the Committee’s efforts to address drug pricing. If you have any questions regarding our comments, please feel free to contact us. We look forward to working with the Committee on this critical issue.
Vice President, Government Relations