On March 27, 2019, the Energy and Commerce Subcommittee on Health held a markup on six bipartisan bills aimed at addressing the price of prescription drugs and six Democratic bills aimed at strengthening the ACA's consumer protections. There was strong bipartisan support for four of the six drug-pricing bills, all of which were passed.

The bills would (i) limit the ability of first-approved generic drug makers from delaying entry of rivals into the market (H.R. 938); (ii) provide generic and biosimilar drug makers more information through FDA databases (Orange and Purple books) about the patents on branded products (H.R. 1520 and H.R. 1503); and (iii) provide the Medicare and Medicaid advisory commissions access to drug pricing and rebate data (H.R. 1781). A bill banning so-called pay-for-delay agreements between drug makers and generic manufacturers saw Republican opposition due in part to its retroactive nature, which Rep. Fred Upton (R-MI) said could lead to generic products being pulled off the market. Republicans also raised concerns with the current version of the CREATES Act (H.R. 965), which would penalize brand-name drug makers that withhold sample products from generic companies, saying that it would encourage unnecessary lawsuits due to the bill's use of revenue to determine the maximum monetary amounts awarded as opposed to treble damages or profits. Both bills ultimately passed with the support of Democrats, who said that the bills need significant deterrents to be effective in preventing anti-competitive and gaming behavior.

In the second part of the markup, Democrats hammered President Trump's recent move to side with a federal court decision to throw out the entire ACA and pushed bills aimed at bolstering the law, reversing the Administration's "sabotage," and protecting consumers with pre-existing conditions. The bills (H.R. 1385, H.R. 1386, H.R. 1425, H.R. 987, H.R. 986, H.R. 1010) were approved along party lines.

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Markup details

H.R. 1781, the "Payment Commission Data Act of 2019," introduced by Rep. Carter (R-GA) would provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information.

• Approved by voice vote.

H.R. 938, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019,"  introduced by Reps. Schrader (D-OR) and Carter (R-GA), would discourage parking of 180-day exclusivity by a first generic applicant by allowing the FDA to approve a subsequent generic application before the first applicant's first date of commercial marketing when the following four conditions have been met: (1) the subsequent application is ready for full approval; (2) a minimum of 30 months has passed since at least one first applicant submitted its application for the drug; (3) any related patent litigation has been fully resolved; and (4) no first applicant is approved.

• Approved by voice vote.

H.R. 1520, the "Purple Book Continuity Act of 2019,"  introduced by Subcommittee Chair Eshoo (D-CA), would amend the Public Health Service Act to codify publication of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book. It also specifies that the Purple Book should be published electronically on the FDA's website and updated routinely and directs the FDA to consider the types of patents that should be listed in the Purple Book.

• Approved by voice vote, as amended.
• A Manager's Amendment from Rep. Anna Eshoo (D-CA) would move the initial publication date to 180 days after enactment; require the Secretary to include the marketing application's approval date and application number, the marketing or licensure status of the biological product, and the listing of exclusivities in the initial publication; and make other changes. Amendment adopted by voice vote.

H.R. 1503, the "Orange Book Transparency Act of 2019,"  introduced by Rep. Kelly (D-IL), would help keep the Orange Book accurate and up-to-date by requiring manufacturers to share complete and timely information with the FDA, as well as helping keep patents listed in the Orange Book relevant to the approved drug product. Patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed promptly.

• Approved by voice vote, as amended.
• A Manager's Amendment from Rep. Kelly (D-IL) would (i) replace with a new subsection "Submission of Patent Information for Brand Name Drugs"; (ii) detail the requirements for applications, including reports on whether the drug is safe, a list of articles used as composition of the drug and a description of the methods used in the processing and packaging of the drug; (iii) add a subsection related to conforming changes to the requirements for subsequent submission of patent information; and (iv) make other changes. Amendment adopted by voice vote.

H.R. 1499, the "Protecting Consumer Access to Generic Drugs Act of 2019,"  introduced by Rep. Rush (D-IL), would make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market.

• Approved by voice vote, as amended.
• A Manager's Amendment from Rep. Rush (D-IL) would (i) prohibit agreements if a subsequent filer agrees to market an authorized generic version of the covered product in lieu of conducting research on or developing the covered product that is the subject of the application described in subsection (f)(8); (ii) add a definition for "authorized generic version"; and (iii) make other changes. Amendment adopted by voice vote.
• An amendment from Rep. Upton (R-MI) would strike language applying the bill retroactively and clarify that the bill only applies to agreements entered after enactment. Amendment rejected, 11-18.

H.R. 965, the "Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019,"  introduced by Reps. Cicilline (D-RI), Sensenbrenner (R-WI), Nadler (D-NY), Collins (R-GA), Welch (D-VT), and McKinley (R-WV), would establish a process by which generic manufacturers could request that the FDA authorize them to obtain sufficient quantities of samples for testing.

• Approved by voice vote, as amended.
• An amendment from Rep. Gianforte (R-MT) would specify that the maximum monetary amount awarded will not exceed the greater of treble damages found or assessed in the civil action or the amount of profits the license holder earned on the covered product during the period specified. Amendment rejected by voice vote.
• A Manager's Amendment from Rep. Welch (D-VT) would (i) insert a subsection under section 4 on shared REMS; (ii) clarify that the term "covered drug" includes any that the Secretary determines would alleviate or prevent a shortage if included; and (iii) make other changes. Amendment adopted by voice vote.
• An amendment from Rep. Bucshon (R-IN) would require an affirmative defense in a civil action if the license holder made an offer to sell a sufficient quantity of the covered product to the eligible product developer for a covered product. Amendment rejected by voice vote.

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