The measure is headed for a vote in the House on Wednesday, and the Senate is expected to soon follow.
FDA documents released late a year ago showed collaboration between the FDA and the medical lobbying group, AdvaMed, even while Congress was holding public roundtables about the bill, according to BloombergBusiness.
Despite the potential for challenges in the Senate, the House will push ahead and vote Wednesday on the $6.3 billion legislation.
Analysts are still picking through the law, which has bipartisan support. Additionally, finding a way to pay for new mandatory funding for medical research at NIH has been an obstacle as well.
The lack of financing caused a stalemate until the unexpected happened: The Affordable Care Act was mortally wounded by the election of Donald Trump. FDA reforms, along with new funding for the National Institutes of Health, were the core of the bill when it was first considered in 2015. While many provisions remain from the version the House passed last year, additions include language created to improve the nation's mental health system and $1 billion over two years to help combat misuse of prescription opioids. "The 21st Century Cures initiative reflects more than two years of bipartisan collaboration focused on a single goal: capitalize on scientific opportunity and American ingenuity to save more lives". It also provides $500 million to the Food and Drug Administration to approve drugs and devices more quickly. And this is where some of the concerns come in.
Industry groups and research advocates generally hailed the new bill as a life-saving measure that would provide billions of dollars in new funding for medical research and seeks to transform an enterprise in which developing a single drug costs more than $1 billion, takes a decade to complete and the vast majority of investigational products fail in clinical trials. So Carome says the legislation isn't all about helping sick people get better. For example, the bill opens the door for the FDA to ease the requirement for the level of evidence when approving a drug that's already been authorized for other diseases and conditions.
"When you're writing the HIPAA rules, one of the things they're anxious about is drug companies getting data to use for marketing purposes". Carome worries that measure could put patients at risk. The bill has morphed into a sprawling piece of legislation that touches nearly every corner of the healthcare industry, including the Food and Drug Administration, Medicare Advantage plans and hospitals.
The faster approach doesn't always work out as planned. Diana Zuckerman, president of the National Center for Health Research, told The Wall Street Journal that the bill "reads like a wish list for pharmaceutical and device companies", and needs careful vetting and public scrutiny.
Even some Republican senators are troubled by provisions in the 21st Century Cures bill.
But Dr. McClellan, who served in the George W. Bush administration and is now director of the Margolis Center for Health Policy at Duke University, expects the new legislation to improve that situation.
"Partisan attacks are not going to help patients like Brooke and Brielle, who are desperate for real solutions", Upton, of St. Joseph, said in the statement. The entire system was geared toward pharmaceutical companies and makers of medical devices. She said it comprises too much give-aways to the pharmaceutical industry and will let companies promote treatments with limited proof of efficacy.
Accusing Republicans of giving handouts to pharmaceutical industry, Democratic Senator Elizabeth Warren of MA warned that the 21st Century Cures Act would speed up the FDA's approval process, which she fears could put consumers at risk.