Legislation

Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs

During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved bipartisan legislation that includes 54 proposals that would aim to reduce health care costs. According to a summary of the bill released by the committee, the Lower Health Care Costs Act of 2019 would reduce costs in three major ways: it would end surprise billing, create more transparency, and increase competition to reduce prescription drug costs.

As part of the goal to reduce prescription drug costs, the bill includes the following provisions that would lower the cost of generic and biosimilar drugs:

• Expedites the drug development process for biosimilar companies through a transparent, modernized, and searchable patent database.
• Improves the Food and Drug Administration’s (FDA) drug patent database by keeping it more up to date—to help generic drug companies speed product development.
• Prevents the abuse of citizens’ petitions that can unnecessarily delay drug approvals.
• Clarifies that the makers of brand biological products, such as insulin, are not gaming the system to delay new, lower cost biosimilars from coming to market; and
• Eliminates a loophole that allows drug companies to get exclusivity—and delay less costly alternatives from coming to market—by merely making slight modifications to an old drug.

Biologics and USP Standards

A provision in the bill that would remove the requirement that biological products meet product quality standards established by the U.S. Pharmacopeia is certain to be subject to contentious discussions if the bill moves forward. FDA officials have pushed for this provision, contending that product-specific monographs for biological products impede technological progress and innovation. A similar provision was included in the 21st Century Cures Act in 2016, but was dropped before the bill’s final passage. Also, the Trump administration included this provision in its FY 2020 budget proposal.

USP officials, along with a coalition of pharmacists and some patient and health care groups, have urged the committee to delete this provision in the bill. These groups maintain that monograph standards are important for ensuring the safety and quality of all drugs and biotech therapies.

Letters and Statements

Cannabis: Congressional Pressure on FDA for Regulations Begins

McConnell Meeting with FDA

On June 27, Senate Majority Leader Mitch McConnell (R-KY) met with Acting FDA Commissioner Dr. Ned Sharpless to remind him of the need for a regulatory framework for cannabidiol (CBD).

In a press statement released subsequent to the meeting, Sen. McConnell lamented that CBD food and dietary supplement products remain in a gray area without clarification from the FDA. “Congress’ intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a workable pathway forward regarding the Agency’s enforcement and potential regulatory plans for certain CBD products,” McConnell declared.

Wyden Letter to FDA

Another key Senate advocate of the hemp provision in the 2018 farm bill recently wrote a letter to the FDA urging the agency to issue guidance on a formal enforcement discretion policy for hemp-derived cannabidiol (CBD) by August 1, 2019. In his letter, Sen. Ron Wyden (D-OR) also urged the FDA to issue promptly an interim final rule that ensures a regulatory pathway for lawful use of CBD as a food additive and in dietary supplements.

While praising the USDA for its intention to release an interim final rule to establish a regulatory framework for commercial hemp production, Sen. Wyden criticized “FDA’s current inaction with respect to regulating hemp-derived CBD in manufactured products.” He lamented that this inaction has resulted in confusion and uncertainty for hemp producers.

Sen. Wyden expressed appreciation for FDA’s current risk-based enforcement approach toward hemp-derived CBD products in the marketplace that focuses on egregious claims, describing it as a critical approach for the advancement of the rapidly growing cannabis industry. He also acknowledged the challenges the FDA faces in expediting a legal pathway for hemp-derived CBD in foods and dietary supplements, especially given that the agency never has used these rulemaking authorities.

However, Sen. Wyden asserted that, absent any formal enforcement discretion guidance, hemp producers and their customers will continue to encounter a “regulatory gray zone.” He also characterized FDA’s recent implications—that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements—as being fully unacceptable.

It is likely that Sen. Wyden sent the letter to the FDA in reaction to recent assertions by agency officials during its recent public hearing and in a detailed statement following the hearing. As we wrote in an earlier alert, based on the remarks and pointed questions during the public hearing on cannabis about the need for more data, it appears unlikely that the FDA would expedite the process for determining a regulatory scheme for CBD products.

Given the number of high-profile congressional supporters for expanding the availability of hemp-derived CBD products, it is likely that congressional pressure on the FDA to expedite the issuance of CBD regulations will only intensify. Additional congressional pressure could be in the form of additional letters to the agency, and the convening of hearings featuring testimony of FDA officials before key committees.

Foreign Drug Inspection Program: House Energy and Commerce Committee Leaders Request GAO Review

A bipartisan group of House Energy and Commerce Committee leaders recently sent a letter to the Government Accountability Office (GAO) requesting a review of the FDA foreign drug inspection program. The committee leaders sent the letter following a series of recent recalls of contaminated blood pressure medications that were manufactured in China and India.

According to a committee press release, the letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Ranking Member Michael Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO), and Oversight and Investigations Ranking Member Brett Guthrie (R-KY).

“The Committee has long held an interest in FDA’s ability to oversee medical products manufactured overseas and in the foreign offices FDA set up to improve its oversight of these and other products,” the bipartisan committee leaders wrote in their letter to GAO. “Therefore, we request that GAO conduct a review of FDA’s drug inspection program.”

Foreign Drug Supply Chain: House Energy and Commerce Leaders Send Letter to FDA Requesting Information on Ensuring Safety

In addition to the letter to the GAO referenced above, the bipartisan group of House Energy and Commerce Committee leaders sent a letter to the FDA following up on an earlier request for information on the agency’s ability to ensure the safety of the drug supply chain. This letter also was a follow-up to a series of recalls involving drugs manufactured overseas.

In their follow-up letter to the FDA, the committee leaders requested additional information from the FDA since the number of recalls of contaminated blood pressure medications continue to expand.

“We remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” the committee’s bipartisan leadership wrote in their letter to the FDA.

Background information in the committee’s press release noted that, since July 2018, there have been multiple recalls issued for a class of drugs known as angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure. The series of recalls appear to be connected to at least two foreign drug manufacturing facilities: Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India. Both facilities had a history of troubling FDA inspection reports prior to the detection of trace amounts of carcinogens.

Imported Cosmetic Products: Letter to FDA Requests Updated Information on Inspections

House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) sent a letter to the FDA recently requesting updated information on the agency’s inspections of imported cosmetic products. According to a committee statement, Pallone’s request follows an alarming announcement from FDA that the agency has not conducted any foreign cosmetic inspections in Fiscal Year (FY) 2019 and does not intend to conduct any inspections in FY 2020.

Chairman Pallone wrote, “Given that FDA noted cosmetic imports have doubled over the last decade and that imports from China have gone up by 79 percent in the last five years, I find it troubling that FDA has not conducted any foreign cosmetic inspections in FY 2019 and intends to conduct no foreign cosmetic inspections in FY 2020.”

“As the demands of consumers grow and evolve, so must the efforts of Congress to protect them. It is in this spirit that I ask that FDA update the Committee on the foreign inspections information I requested in my December 20, 2016 letter to reflect data for FY 2017-2019,” Chairman Pallone added.

Chairman Pallone specifically requested information from the FDA on its foreign inspections data from FY 2017-2019, including:

• the number and kinds of personal care products imported each year;
• the number of imported products subjected to inspections each year; and,
• the number of contaminated products intercepted each year.

Pallone also requested that the FDA provide the committee with other materials that would help in the development of cosmetics legislation.

Upcoming Hearings

No hearings relevant to FDA/life science issues have been scheduled.