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Congress's enactment of 21st Century Cures legislation may have given pharmaceutical manufacturers an early Christmas present, but some concerns are being voiced, writes Jill Wechsler.
Congress gave pharmaceutical manufacturers an early Christmas present by enacting the 21st Century Cures legislation with its many provisions that shore up FDA operations and support biomedical research at the National Institutes of Health (NIH), including the cancer “moonshot” and Obama’s Personalized Medicine Initiative. President Obama is slated to sign the measure into law as one of the final acts of his administration.
Sponsors expanded support for the bill by adding measures to fund state opioid treatment programs, expand mental health services and support research on regenerative medicine. A handful of liberal Democrats objected that nothing in the bill controls drug prices, and that patient safety would be compromised by permitting wider use of data outside traditional clinical trials to approve new drug uses and medical devices.
Several leading Senators sought a last-minute addition to help generic drug makers gain access to brand products for bioequivalent testing of competitive products. That change was withdrawn to avoid delays in finalizing the larger bill, but is expected to resurface next year.
The sweeping package offsets these complaints with provisions that further pediatric research, patient-focused drug development, qualification of biomarkers, and the development of antibiotics and treatments for rare conditions. Sponsors of new drugs backed measures that encourage the use of novel clinical trials designs and study modeling and permit wider reliance on real world evidence to support approval of added indications for marketed medicines. The Pew Charitable Trusts praised the added support for opioid treatment and a new pathway for developing much-needed antibiotics. Biopharm companies applauded provisions that further the development of vaccines and drug medical countermeasures. And FDA stands to gain from language that will help it hire the experts it needs to evaluate new medical products.
A main disappointment is that the additional $4.8 billion over 10 years for NIH and $500 million for FDA is authorized, but not appropriated, opening the door to future cuts in promised resources. Advocates emphasized that Congress will need to ensure that the funds included in “Cures” remain additive to money provided by the regular appropriations process.