House Republicans To Offer Up Their Own Plan To Combat High Drug Prices To Counter Dems’ Aggressive Bill
The Republicans' bill would enact a $3,100 cap on out-of-pocket drug expenditures for Medicare beneficiaries and add monthly caps as well. The proposals are identical to ones that are in the Senate's version of the legislation. In other pharmaceutical news: how to pay for expensive sickle cell treatments; FDA's approval speed generates alarm; the government investigates possible carcinogens in diabetes drug; lawmakers urge HHS to probe patient assistance programs; and more.
Stat:
House GOP To Introduce Competing Drug Pricing Legislation
Republicans on Monday are set to accelerate Capitol Hill’s drug pricing chaos with a new proposal to lower the cost of prescription medicines, according to a summary document obtained by STAT. It’s intended to compete with a Democratic package from House Speaker Nancy Pelosi that is expected to come up for a vote this week. The Republican lawmakers’ new proposal includes a collection of bipartisan proposals collectively rebranded as the “Lower Costs, More Cures Act.” The House bill, according to Republican aides, is a “good-faith effort” to overcome partisan drug pricing squabbles, and includes a number of provisions that could conceivably become law before the end of 2019. (Facher, 12/9)
The Hill:
House Progressives May Try To Block Vote On Pelosi Drug Bill
House progressives are considering voting against a procedural motion to proceed to Speaker Nancy Pelosi’s (D-Calif.) signature bill to lower drug prices next week unless they get changes to the measure, effectively threatening to stop the bill in its tracks. The Congressional Progressive Caucus (CPC) on Friday is conducting a whip count of its 98 members to see how many would be willing to vote "no" on what is known as the rule for the legislation. (Sullivan, 12/6)
The New York Times:
Two New Drugs Help Relieve Sickle-Cell Disease. But Who Will Pay?
The Food and Drug Administration recently approved two transformative new treatments for sickle-cell disease, the first in 20 years. But the drugs are wildly expensive, renewing troubling questions about access to cutting-edge medicines. Adakveo, made by Novartis, can prevent episodes of nearly unbearable pain that occur when malformed blood cells get stuck in blood vessels. Approved only for patients aged 16 and over, it is delivered as an infusion once a month. (Kolata, 12/7)
Bloomberg:
FDA Approving Drugs At Breakneck Speed, Raising Alarm
The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer advocates. Global Blood Therapeutics Inc., maker of a new sickle cell disease drug called Oxbryta, built a booth to showcase the medicine at the annual meeting of the American Society of Hematology that begins this weekend -- even though the Food and Drug Administration’s deadline for approval was Feb. 26. (Cortez and Flanagan, 12/6)
Atlanta Journal-Constitution:
Diabetes Drug Cancer: FDA Investigates Metformin For Contamination
Add the popular diabetes drug metformin to the list of medications possibly contaminated with the carcinogen N-Nitrosodimethylamine, or NDMA. This same carcinogen has led to recalls of blood pressure and heartburn medications. (Clanton, 12/6)
Stat:
Lawmakers Ask HHS For More Oversight Of Patient Assistance Programs
Amid ongoing concern about the use of patient assistance programs by the pharmaceutical industry, two lawmakers want the Inspector General of the Department of Health and Human Services to update its oversight and require more disclosure from the foundations about their operations. In arguing their case, the lawmakers maintained that some drug makers game the system by finding ways to boost sales of their own medicines while also benefiting from tax breaks. At the same time, they contended that programs favor expensive brand-name medicines over lower-cost generics and sometimes fail to help patients with the most need. (Silverman, 12/6)
Stat:
Revamped Senate Drug Pricing Package Is A Little Better For Seniors
Leaders of a key Senate committee unveiled a new version of a sweeping, bipartisan drug pricing bill Friday, and they’ve devised a novel plan to get it signed into law. The bill hasn’t changed much from the version that was narrowly passed out of the Senate Finance Committee in July — though a handful of tweaks offer further benefits to seniors. Since then, however, the bill’s political prospects have grown brighter, particularly after key Trump administration officials endorsed it over a far more progressive proposal from House Speaker Nancy Pelosi. (Florko, 12/6)
Stat:
More Hospital Drug Spending Going Toward Cancer Immunotherapies
Amid intense scrutiny over prescription drug costs, a new analysis finds some hospitals are spending a larger share of their budgets for new cancer and migraine treatments, as well as for a biosimilar version of a brand-name drug that is used to prevent white-cell depletion in patients given chemotherapy. Not surprisingly, the spending reflects a growing trend among hospitals to shell out more of their dollars for outpatient infusion treatments and, in particular, costly specialty drugs, according to Bonnie Lai, vice president of product management at Lumere, a research and analytics firm that focuses on hospitals and generated the data from 26 facilities across four hospitals systems. (Silverman, 12/6)
Stat:
Activists Seek To Block Gilead Patent Extension On Lucrative HIV Drug
In an unusual move, an advocacy group asked federal authorities to reject a request by Gilead Sciences (GILD) for a three-year patent extension on an HIV drug because the company allegedly lied about important information in its application. The group argued in an emergency petition with the U.S. Patent and Trade Office that Gilead concealed a decision to delay development of the drug, called TAF, in order to thwart generic competition and “game” the patent system. In the process, the company reaped billions of dollars in additional sales while knowingly marketing an older drug that the company believed was not as safe. (Silverman, 12/6)