Chuck Grassley

United States Senator from Iowa

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Judiciary Committee Leaders Seek FTC Review of EpiPen Maker for Potential Antitrust Violations

Nov 07, 2016

WASHINGTON – Senate Judiciary Committee Chairman Chuck Grassley and Ranking Member Patrick Leahy today are calling on the Federal Trade Commission to review Mylan Pharmaceuticals’ business practices with respect to EpiPens for possible anticompetitive behavior.  The senators’ request follows news reports that Mylan engaged in exclusive contracts with schools, precluding them from purchasing products that compete with the auto-injector to treat severe allergic reactions.

“Increasing patient access to safe, effective and affordable medications has long been a shared priority of ours.  We also share a strong belief that potential anti-competitive actions by drug industry participants must be aggressively investigated because of their impact on competition and drug costs,” the senators said in a letter to FTC Chairwoman Edith Ramirez.  “The FTC’s role in preserving a competitive marketplace and protecting consumers is critical, and due to the dramatic increase of the price of drugs across the board, the FTC should be vigilant in its scrutiny of this market.”

Mylan has come under recent scrutiny for dramatic increases in the price of EpiPen and revelations that Mylan misclassified EpiPen in the Medicaid Drug Rebate Program, allowing the company to pay lower rebates than it should have.

The Judiciary Committee has scheduled a hearing to explore a reported settlement agreement between the Justice Department and Mylan related to the misclassification issue.  

Grassley and Leahy were joined by Senators Amy Klobuchar, Richard Blumenthal and Ron Johnson in an earlier request to the Food and Drug Administration for details on its approval of generic equivalents to EpiPen, which could provide a more affordable alternative and lower EpiPen’s price through expanded competition.

Full text of Grassley and Leahy’s letter to the FTC follows:

November 7, 2016

VIA ELECTRONIC TRANSMISSION

The Honorable Edith Ramirez
Chairwoman
Federal Trade Commission
600 Pennsylvania Avenue, NW
Washington, DC  20580

Dear Chairwoman Ramirez:

There are significant concerns with the pricing of Mylan Pharmaceutical’s (Mylan) product, EpiPen, a self-injectable remedy for severe allergic reactions.  Recent consumer complaints and media reports have brought to light the tremendous increase in price for EpiPens, as well as possible unlawful and anti-competitive activity by Mylan in promoting its product.  These reports have suggested that Mylan misclassified the EpiPen for purposes of the Medicaid Drug Rebate Program, as well as engaged in questionable anti-competitive conduct, to include possible exclusionary conduct, exclusive contracting, and other monopolistic behavior, to the detriment of millions of patients and the American taxpayer.  For example, news reports indicate that Mylan entered into contracts with schools that would preclude the schools from purchasing EpiPen competitors.

Increasing patient access to safe, effective and affordable medications has long been a shared priority of ours.  We also share a strong belief that potential anti-competitive actions by drug industry participants must be aggressively investigated because of their impact on competition and drug costs.  Over the years, the Federal Trade Commission (FTC) has developed significant expertise with respect to competition in the drug market, and has analyzed potentially unlawful business practices by both brand and generic drug companies.  We have worked with the FTC on a number of occasions to address anti-competitive tactics by drug companies that undermine the entry of less expensive alternatives in the market, restrict patient access to life-saving drugs, and keep medicine prices high for consumers.  

We therefore request that the FTC look into whether Mylan engaged in any anti-competitive practices in violation of the antitrust laws with respect to the EpiPen and, if so, take appropriate action to safeguard patients.  The FTC’s role in preserving a competitive marketplace and protecting consumers is critical, and due to the dramatic increase of the price of drugs across the board, the FTC should be vigilant in its scrutiny of this market.  

We appreciate your attention to this matter.  We look forward to receiving your response by November 30, 2016.

Sincerely,
 
Charles E. Grassley                          
Chairman
Committee on the Judiciary
 
Patrick Leahy  
Ranking Member
Committee on the Judiciary
 

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