u.s. senate and house negotiators are in final stages of talks toward legislation that would boost funding for the national institutes of health, provide states with $1 billion for opioid-addiction treatment and improve access to mental-health treatment. the bill, which is likely to become completed in the next few days, will also have potentially significant impact on the regulation of medical devices and drugs. the house is scheduled to vote on some version of the legislation as early as wednesday. republican committee chairmen on saturday released what they termed a <u+201c>final<u+201d> version of the bill, which they are calling 21st century cures. people familiar with the talks, however, said that over the weekend there are major provisions to be hammered out, especially regarding food and drug administration regulation of drugs and devices. one of those people said on saturday that there was still the possibility that this emerging deal would fall apart. president barack obama likely would sign such legislation into law, which would be among his last acts in the white house. president-elect donald trump, on the campaign trail, also advocated for more investment to help curb addiction, but his positions on other provisions in the measure are less known. house energy and commerce committee chairman fred upton (r-mich.) and senate health committee chairman lamar alexander (r-tenn.) on saturday said the $6.3 billion legislation would provide up to $4.8 billion in additional funding to the nih over 10 years, as well as for such projects as vice president joe biden <u+2019>s <u+201c>cancer moonshot<u+201d> and other scientific ventures. during the same period, the bill would provide $500 million in new funding for the fda, provide $1 billion in grants to states to grapple with the opioid crisis and help ease access to mental-health treatment. the nih money is slightly more than half the $8.75 billion originally passed by the house a year ago in a bill that didn<u+2019>t make it through the senate<u+2014>also dubbed the 21st century cures act. that bill contained a variety of controversial provisions that would have jeopardized the safety of new drugs and medical devices, in the view of several consumer advocates such as public citizen health research group. provisions concerning the fda are among those still being negotiated. democratic senators and staff earlier this year objected to several of them and successfully kept them out of senate legislation. but that was when it seemed democrat hillary clinton would win the white house. now that republican mr. trump is president-elect and likely wouldn<u+2019>t veto pro-industry provisions, democrats feel they have more leverage to negotiate under the obama administration. if negotiators reach a final deal, it likely will gain considerable bipartisan support in both chambers. the current bill arose from weeks of negotiations between republican and democratic leaders of the house energy and commerce committee and the senate committee on health, education, labor and pensions. in the house, the lead negotiators have been reps. upton, frank pallone (d., n.j.) and diana degette (d., colo.) and their staffs. their counterpart negotiators in the senate are sens. alexander and patty murray (d., wash.) democrats all along have wanted more money for research at nih and to prevent and treat opioid addiction. republicans generally agree, while seeking to include pro-industry provisions that could limit the regulatory authority the fda has over drugs and medical devices. republican officials have described such provisions as designed to speed new therapies to market and into treatment of patients. in particular, sen. mitch mcconnell (r., ky.), the senate majority leader, has urged legislation that would limit the fda<u+2019>s ability to regulate products from research on human stem cells. a senior republican staffer said the mental-health legislation would make it easier for insurers to provide more extensive coverage for mental-health treatment. a press statement from sen. alexander and rep. upton said the fda portion of the legislation will <u+201c>help bring drugs and devices to market more quickly and at less cost by making needed reforms to the fda.<u+201d> it cited expedited review for breakthrough devices, <u+201c>increased patient involvement in the drug approval process, [and] a streamlined review process for combination products that are both a drug and device,<u+201d> among others. however, language of such provisions is still being shaped, according to a person familiar with the talks. a consumer advocate who is skeptical of the draft bill is diana zuckerman, president of the national center for health research in washington. she said the bill <u+201c>reads like a wish list for pharmaceutical and device companies. it deserves to be carefully vetted in public by experts representing different points of view, including public health and patient safety issues. it was negotiated behind closed doors and shouldn<u+2019>t be passed without scrutiny and major improvements.<u+201d> write to thomas m. burton at tom.burton@wsj.com
lawmakers try for year-end bill on medical research, devices and opioid addiction  - wsj
thomas m. burton