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Rx Drugs

Friday, 23 June 2017

A leaked draft of an alleged White House executive order on drug prices calls for value-based contracts, lower Medicare beneficiary out-of-pocket costs, drug rebate reforms, restricted hospital drug discounts, faster FDA approvals and higher prices in other countries.

Friday, 23 June 2017

Pfizer announced Thursday (June 22) that FDA has rejected its epoetin alfa biosimilar due to good manufacturing practice violations, despite an advisory committee recommending approval last month.

Friday, 23 June 2017

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.

Friday, 23 June 2017

A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.

Friday, 23 June 2017

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.

Friday, 23 June 2017

Recently unveiled over-the-counter (OTC) monograph legislation is all the more important to reducing the monograph backlog given that FDA's fiscal 2018 budget justification maintains fiscal 2017 funding levels for the agency's OTC review processes, the Pew Charitable Trusts recently recently told Inside Health Policy.

Thursday, 22 June 2017

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.

Wednesday, 21 June 2017

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

Wednesday, 21 June 2017

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.

Tuesday, 20 June 2017

FDA will create a “Medical Innovation Development Plan” aimed at lowering health care costs by facilitating development of drugs to treat costly rare diseases through improved adaptive trial designs and statistical tools, agency chief Scott Gottlieb announced Tuesday (June 20).

Tuesday, 20 June 2017

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.

Monday, 19 June 2017

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Monday, 19 June 2017

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.

Friday, 16 June 2017

President Donald Trump could use an executive order to direct the CMS innovation center to waive rules that would make it easier for drug companies and insurance companies to use value-based contracts, said Paul Howard, director and senior fellow at the Manhattan Institute.

Friday, 16 June 2017

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).

Friday, 16 June 2017

FDA will hold a two-day public workshop early next month to discuss the regulatory challenges it faces in assessing the real-world, post-market effects of abuse-deterrent opioids, the agency announced Tuesday (June 13).

Friday, 16 June 2017

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.

Thursday, 15 June 2017

Academics and policy experts said that value-based contracts, real-world evidence and drug repurposing for off-patent and on-patent drugs could help to spur competition and lower drug prices.

Wednesday, 14 June 2017

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.

Wednesday, 14 June 2017

Mental health advocates are blasting the Senate Republican proposal to set up a separate funding pool for the care of opioid addicts currently covered through Medicaid expansion but who under the American Health Care Act would not be allowed to re-enroll in Medicaid once they cycle off.

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