Rx Drugs

CHICAGO -- A representative from pharmaceutical company Sarepta -- manufacturer of the controversial Duchenne muscular dystrophy drug Exondys 51 -- touted FDA's use of regulatory flexibility to approve Exondys 51, saying the approach has been frequently used for oncology drugs and could be a boon for the rare disease space.

The Consumer Healthcare Products Association (CHPA), Pew Charitable Trusts and American Academy of Pediatrics along with four other health-focused groups recently penned a letter to Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) showing support for the senators' revised draft of their bill intended to reform FDA's over-the-counter (OTC) drug monograph system.

FDA Commissioner Scott Gottlieb is acting on his promise to congressional appropriators that the agency will hold a public meeting examining potentially anti-competitive actions meant to keep generics off the market.

House Democrats who met with the president in the spring to discuss drug-price policies are urging him to take aggressive action to curb price increases in an anticipated executive order. However, news reports indicate President Donald Trump is considering measures that are friendly to the drug industry.

Sen. Susan Collins (R-ME) is considering using Medicare Part D as leverage to stop brand drug makers from gaming FDA drug-safety policy to thwart generic competition.

In the wake of the U.S. Supreme Court's reversal of a lower court decision on patent exhaustion, which some see as partially clearing the way for drug importation, legal experts argue that the pharmaceutical industry will now turn to contract disputes over licensing to fight importation.

Changing CMS’ controversial policy of lumping biosimilars that reference the same biologic under a single same billing code is not a high priority for the Trump administration, two sources in touch with the White House said Tuesday (June 13).

FDA's recent decision to withdraw Endo Pharmaceuticals' opioid Opana Extended Release (ER) from the market has sparked debate between those concerned that pulling the opioid from the market could have a “chilling effect” on developers and those who say the product should never have been approved in the first place.

House Energy & Commerce health subcommittee Chair Mike Burgess (R-TX) said the committee has “teed up” a hearing on the 340B drug discount program, and a committee spokesperson said lawmakers are waiting for the Health Resources and Services Administration to respond to their questions about the program before deciding next steps.