Congressional Developments on Life Science and Consumer Product Issues

Legislation

Citizen Petitions: House Subcommittee Approves Bill to Prevent Overuse

To address the abuse of citizen petitions that delay or impeded generic drugs from coming to market, the House Energy and Commerce Subcommittee on Health on November 13 approved by voice vote H.R. 2387, the “Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act.”

The bipartisan bill, introduced by Representatives Andy Levin (D-MI), and Francis Rooney (R-FL), would allow the Food and Drug Administration (FDA) to expeditiously reject a citizen petition submitted to delay approval of a generic drug, and directs the Department of Health and Human Services (HHS) to report such citizen petitions to the Federal Trade Commission (FTC). The bill also would require drug manufacturers to file a petition within 60 days of receiving actionable information. Under the bill, the FDA would be directed to report additional information to Congress, including: time and resources spent on each petition; timing of petitions relative to patent expiration, and; any delay in approval of a competing generic drug caused by such petition.

Product Hopping: House Judiciary Approves Bill to Prohibit Anticompetitive Activity

On November 20, the House Judiciary Committee approved H.R. 5133, the Affordable Prescriptions for Patients Through Promoting Competition Act. The bill, introduced by Representatives David Cicilline (D-RI) and Jerold Nadler (D-NY), would prohibit pharmaceutical companies from engaging in anticompetitive “product hopping” by strengthening the FTC’s ability to bring and win cases against pharmaceutical companies that engage in all forms of product hopping.

Biosimilar Patent Dance: House Judiciary Approves Patent Litigation Bill

During the same November 20 markup in which it approved product hopping legislation, the House Judiciary Committee also approved H.R. 3991 – the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. The bill would aim to address the so-called “patent dance” and expedite the approval of lower-cost generic versions of complex biologic drugs.

The sponsor of the bill, Representative Hank Johnson (D-GA), argued that the bill would boost an already robust biosimilar application process by streamlining and simplifying the patent litigation process, thus expediting access to affordable lifesaving drugs.

Drug Pricing: House Approves Disclosure of Drug Discounts Act

On October 28, the House approved H.R. 2115, the “Public Disclosure of Drug Discounts Act” by a vote of 403-0. The bill would require the HHS to make public the aggregate rebates, discounts, and price concessions that pharmacy benefit managers (PBMs) negotiate with drug manufacturers. The also would require Medicare prescription drug plan sponsors to implement an electronic, real-time benefit tool capable of integrating with at least one prescriber’s electronic prescribing system or electronic health record, allowing beneficiaries to have access to better information about their drug plan at the point of prescribing.

Drug Pricing: House Committee Approves “Lower Drug Costs Now Act”

On October 17, the House Energy and Commerce Committee approved H.R. 3, the “Lower Drug Costs Now Act by a 30-22 vote. The bill would aim to lower prescription drug costs by allowing the federal government to negotiate lower prices and prevent drug companies from charging more than other countries. The bill also would create a new, $2,000 out-of-pocket limit on prescription drug costs for seniors in Medicare Part D.

The bill also was approved by the House Ways and Means and the Education and Labor Committees.

Wilson Sonsini recently issued an alert reporting that a group of prominent venture capitalists (VCs) issued a strong warning to Congress that the bill would “severely constrain” the VC’s ability to invest in future biomedical innovation.

Drug Pricing Agency: Presidential Candidates Introduce Bill to Establish Agency

Senator Cory Booker (D-NJ) recently announced the introduction of legislation that would create an independent agency—the Bureau of Prescription Drug Affordability and Access—which would be responsible for conducting reviews of drug prices and determining an appropriate list price. Under the bill, which was co-sponsored by Sens. Bernie Sanders (I-VT) and Kamala Harris (D-CA), companies that do not comply with the bureau-reviewed list price could have their government-granted exclusivity voided, allowing other entities to produce the drug.

Hearings

Product Hopping: House Committee Holds Hearing on How Pharmaceutical Companies Game the System

The House Energy and Commerce Subcommittee on Consumer Protection and Commerce recently held a hearing titled, “Exposing How Pharmaceutical Companies Game The System.” The hearing focused on different terms used to describe the problem, including: “product hopping,” “hard switches,” “soft switches,” and “evergreening.”

Subcommittee Chair Jan Schakowsky (D-IL) argued that, regardless of phrasing, “the bottom line is drug manufacturers are gaming the system to make more money at consumers’ expense. And that has to stop.”

Drug Safety: House Committee Holds Hearing on Safeguarding the Global Supply Chain

The House Energy and Commerce Health Subcommittee convened a hearing on October 30 titled, “Safeguarding the Pharmaceutical Supply Chain in a Global Economy.” With manufacturers obtaining pharmaceutical ingredients from manufacturers overseas, particularly from China and India, Committee Chairman Frank Pallone noted that some of the ingredients from abroad have caused serious quality concerns with certain drug products.

The focus of the hearing was to examine whether the FDA has the authority it needs to address these concerns and to remain vigilant over the marketplace. The hearing also discussed the need to ensure that manufacturers are still incentivized to produce their pharmaceutical ingredients and products domestically.

Bill Introductions

Senate

• S. 2740 – Introduced on October 30 by Senators Johnny Isakson (R-GA) and Bob Casey (D-PA). A bill to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. The bill was referred to the Senate Health, Education, Labor, and Pensions (HELP) Committee.
• S. 2886 – Introduced on November 18 by Senator Martha McSally (R-AZ); co-sponsored by Senators Cory Booker (D-NJ), Rob Portman (R-OH), and Sheldon Whitehouse (D-RI). A bill to prohibit the use of animal testing for cosmetics and the sale of cosmetics tested on animals. The bill was referred to the HELP Committee.

House

• H.R. 4633 – Introduced on October 11 by Rep. Anna Eshoo (D-CA); co-sponsored by Rep. Gary Peters (D-MI). A bill to amend the 21st Century Cures Act to reauthorize funding for FDA innovation projects. The bill was referred to the House Energy and Commerce Committee.
• H.R. 4667 – Introduced on October 11 by Rep. Mikie Sherrill (D-NJ); co-sponsored by Reps. Mike Levin (D-CA) and Abigail Spanberger (D-VA). A bill to amend the 21st Century Cures Act to reauthorize funding for National Institutes of Health (NIH) innovation projects. The bill was referred to the House Energy and Commerce Committee.
• H.R. 4711 – Introduced on October 17 by Rep. Dan Lipinski (D-IL). A bill to deny any deduction for advertising prescription drugs. The bill was referred to the House Ways and Means Committee.
• H.R. 4712 – Introduced on October 17 by Rep. Madeleine Dean (D-PA); co-sponsored by Reps. Marc Veasey (D-TX), Buddy Carter (R-GA), and David McKinley (R-WV). A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs. The bill was referred to the House Energy and Commerce Committee.
• H.R. 4811 – Introduced on October 28 by Rep. Roger Marshall (R-KS); co-sponsored by Rep. Anthony Brindisi (D-NY). A bill to ensure that consumers can make informed decisions in choosing between meat products such as beef and imitation meat products. The bill was referred to the House Energy and Commerce and Agriculture Committees.
• H.R. 5017 – Introduced on November 8 by Rep. Sean Patrick Maloney (D-NY); co-sponsored by Reps. Grace Meng (D-NY) and Jan Schakowsky (D-IL). A bill to treat as misbranded cosmetics with packaging or labeling using the term “natural” unless the product meets certain standards. The bill was referred to the House Energy and Commerce Committee.
• H.R. 5039 – Introduced on November 12 by Rep. Dan Lipinski (D-IL). A bill to lower the prices of excessively costly life-sustaining prescription drugs under Medicare part D by requiring the HHS to negotiate their prices. The bill was referred to the House Energy and Commerce, and Ways and Means Committees.
• H.R. 5097 – Introduced on November 14 by Rep. Grace Ming (D-NY); co-sponsored by Reps. Alcee Hastings (D-FL), Eleanor Holmes Norton (D-DC), Jerrold Nadler (D-NY), Rashida Tlaib (D-MI), Gilbert Ray Cisneros, Jr. (D-CA), and Veronica Escobar (D-TX). A bill to require greater notification to the public regarding product recalls. The bill was referred to the House Energy and Commerce Committee.
• H.R. 5141 – Introduced on November 18 by Rep. Donald Beyer (D-VA); co-sponsored by Reps. Vern Buchanan (R-FL), Tony Cardenas (D-CA), Paul Tonko (D-NY), and Ken Calvert (R-CA). A bill to substantially restrict the use of animal testing for cosmetics. The bill was referred to the House Energy and Commerce Committee.