House’s New ‘Right To Try’ Legislation Ensures FDA’s Oversight Of Terminally Ill Patients Getting Untested Drugs

The Wall Street Journal: House Introduces ‘Right To Try’ Legislation To Permit Use Of Unproven Drugs For Dying Patients
A House of Representatives committee early Saturday issued its version of “Right to Try” legislation that would enable a terminally ill patient to use an unproven, investigational drug in an effort to save that person’s life. Such legislation was passed in August by the Senate and supported by President Donald Trump in his State of the Union address. The conservative Goldwater Institute, which has helped such bills become law in 38 states, has been a prime driver of the idea. (Burton, 3/10)

Stat: Key Republican Lawmaker Releases New 'Right-To-Try' Legislation
The legislation, from House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), is more limited than an earlier measure championed by Sen. Ron Johnson (R-Wis.) that passed the Senate last fall. Walden’s version would ensure that the Food and Drug Administration has more oversight of the process. Like the Senate bill, it includes liability protections for drug companies and providers who decide to use the process. Walden’s bill also limits the process to patients who are likely to die “within a matter of months” or “severely premature.” In a statement, Walden and health subcommittee chairman Michael Burgess (R-Tex.) said they believe the legislation is now ready for a vote in the House of Representatives. (Mershon, 3/10)

The Hill: House To Vote Tuesday On 'Right To Try' Drug Bill 
The House will vote Tuesday on a newly released Right to Try Act aimed at letting very sick patients request access to treatments the Food and Drug Administration (FDA) hasn’t yet approved. The legislation is a priority for the White House. President Trump called on Congress to pass the legislation in his State of the Union address in January. Vice President Pence is also a staunch supporter of right to try laws, signing a bill when he was governor of Indiana. (Roubein, 3/11)

Modern Healthcare: Week Ahead: 340B Gets Its Turn In The Senate
The Senate this week is turning its focus to 340B, the drug discount program that has fueled a fierce Capitol Hill lobbying battle in the U.S. House of Representatives for months. Senate health committee Chairman Lamar Alexander (R-Tenn.) called a hearing for Thursday, saying he will focus on gathering information from stakeholders. "Congress created this program to help some of the most vulnerable people in our country afford their medications to treat HIV, hepatitis C, diabetes or cancer," Alexander said in the hearing notice. "I am looking forward to hearing from many of those involved in how the program is working, and what steps, if any, the federal government should take to strengthen the program and ensure patients are receiving benefits." (Luthi, 3/10)

Politico Pro: Drug Industry Pushes To Roll Back 'Doughnut Hole' Changes In Spending Bill
The drug industry appears to be slowly progressing in its quest to undo a multibillion-dollar cut in the budget caps deal that would have forced pharma to pick up more of the tab for prescription spending in the Medicare doughnut hole. It’s still unclear whether the prescription drug lobbying behemoth PhRMA and the industry will be able to completely, or more likely, partially repeal the provision, but the clock is ticking: House leaders want to get the omnibus spending bill — the most likely vehicle for any change — passed next week, an ambitious deadline ahead of the expiration of government funding on March 23. (Karlin-Smith adn Haberkorn, 3/9)

Stat: McCaskill Plans A Bill To Force Pharma To Disclose Payments To Nonprofits And Advocacy Groups 
Seeking to toughen the Sunshine Act, Sen. Claire McCaskill (D-Mo.) plans to introduce a bill that would require drug makers to report payments that are made to nonprofit organizations and patient advocacy groups, according to several sources familiar with the effort. The move comes eight years after the Sunshine Act was created in response to concerns that industry payments were unduly influencing medical research and practice, an issue that arose after a Senate Finance Committee probe. The law was subsequently folded into the Affordable Care Act and a federal database was launched in 2014 to which companies must report payments to physicians. (Silverman, 3/9)

And in other pharmaceutical news —

Reuters: Walgreen Must Face Lawsuit Over U.S. Generic Drug Pricing
A federal judge on Friday ordered Walgreen Co to face most of a proposed class action lawsuit accusing the drugstore chain of fraudulently overcharging customers for a decade when they bought generic drugs through private insurance, Medicare or Medicaid. Walgreen was accused of wrongly requiring insured customers to pay more than members of its Prescription Savings Club, who for a low annual fee could buy more than 500 widely prescribed generic drugs for $5, $10 and $15 for 30-day prescriptions, and $10, $20 and $30 for 90-day prescriptions. (Stempel, 3/9)

Bloomberg: Martin Shkreli Sentenced To Seven Years In Prison 
Martin Shkreli, the pharmaceutical industry’s enfant terrible, was sentenced Friday to seven years in prison, putting an end to a saga that captivated and sometimes enraged Washington, Wall Street and the tabloids. The brash 34-year-old — who gained notoriety for jacking up the price of a life-saving anti-infection drug — was convicted in August of lying to investors in his hedge funds and manipulating shares in Retrophin Inc., a biotech company he founded. Prosecutors sought a sentence of at least 15 years for the securities fraud. Shkreli, who once proclaimed “you can’t quell the Shkrel,” asked for as little as a year. (Hurtado and Larson, 3/9)