S.1095 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act; Stop STALLING Act (119th Congress)
Summary
S.1095, the Stop STALLING Act, aims to curb the filing of sham citizen petitions intended to delay the approval of generic drugs and biosimilars. It empowers the Federal Trade Commission (FTC) to take action against those who submit such petitions, fostering competition within the pharmaceutical market.
The bill defines 'sham' petitions as those that are objectively baseless and designed to interfere with a competitor's business through governmental processes. The Department of Health and Human Services (HHS) plays a role by identifying petitions submitted with the primary purpose of delaying drug approval.
Ultimately, this bill seeks to ensure that legitimate public health concerns are addressed efficiently while preventing anti-competitive practices that inflate drug costs.
Expected Effects
The primary effect of this bill will be to expedite the approval process for generic drugs and biosimilars by deterring the filing of frivolous petitions. This should lead to increased competition in the pharmaceutical market.
As a result, consumers may see lower drug prices due to the availability of more affordable generic alternatives. The FTC will have increased authority to penalize companies engaging in anti-competitive behavior through the misuse of citizen petitions.
Potential Benefits
- Reduced Drug Costs: By preventing delays in generic drug approvals, the bill can lead to lower prices for consumers.
- Increased Competition: The bill promotes a more competitive pharmaceutical market by discouraging anti-competitive tactics.
- Faster Access to Medications: Expedited approval processes mean patients gain quicker access to needed medications.
- FTC Empowerment: The bill strengthens the FTC's ability to combat unfair competition in the pharmaceutical industry.
- Focus on Legitimate Concerns: The bill facilitates the efficient review of petitions filed in good faith to raise legitimate public health concerns.
Potential Disadvantages
- Potential for Overreach: There is a risk that the FTC could potentially overreach in its enforcement, penalizing legitimate petitions raising valid concerns.
- Increased Litigation: The bill may lead to increased litigation as companies challenge FTC determinations of 'sham' petitions.
- Unintended Consequences: The presumption clause could inadvertently penalize companies for raising legitimate concerns if HHS makes an incorrect determination.
- Complexity of Enforcement: Determining whether a petition is 'objectively baseless' can be complex and subjective, leading to inconsistent enforcement.
- Limited Scope: The bill focuses solely on citizen petitions and may not address other anti-competitive practices in the pharmaceutical industry.
Constitutional Alignment
The bill's focus on promoting competition and preventing anti-competitive practices aligns with the general welfare clause of the Constitution's preamble. It aims to 'promote the general Welfare' by ensuring access to affordable medications.
However, the bill's potential impact on the right to petition the government, as protected by the First Amendment, must be considered. The bill includes safeguards to protect legitimate petitions, but the risk of chilling protected speech remains.
The bill's delegation of authority to the FTC and HHS is consistent with established constitutional principles regarding the delegation of regulatory powers to administrative agencies.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).