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July 6, 2015

REPORTERS’ MEMO

Don’t Buy the Snake Oil: 21st Century Cures Would Reduce Safety of Medications and Devices

House to Vote Soon on Bill; Leadership Aims to Pass Into Law by End of Year

A measure being sold as enabling scientific innovation and medical breakthroughs for America would undermine efforts to approve safe and effective drugs and medical devices. The bill is rapidly moving through Congress. It should be stopped.

As soon as Wednesday, the U.S. House of Representatives will vote on H.R. 6, the 21st Century Cures Act. The House Energy and Commerce Committee approved the measure unanimously on May 21.

The narrative around this bill – that it is a smart bipartisan compromise – is highly misleading, and it is important that your readers understand the potential consequences for public health if this flawed legislation became law.

The negative provisions were added as part of a horse trade that enabled the bill to achieve the bipartisan support it has been so lauded for: The bill increases the budget of the National Institutes of Health, currently at $30.3 billion per year. In exchange, the legislation calls for dangerous regulatory changes and financial incentives for pharmaceutical and medical device companies. These changes and incentives would put patient safety at risk and undermine the public’s health.

1.  21st Century Cures would further undermine the U.S. Food and Drug Administration’s (FDA) ability to ensure the safety and efficacy of medical devices (Sections 2222 and 2221).

Section 2222 would allow for new high-risk medical devices to be approved by the FDA based on case studies or medical journal articles alone. High-risk devices should not be approved on the basis of uncontrolled case studies of just one, two or even a series of patients (in essence, clinical anecdotes). Medical journal articles often leave out critical information because of space limitations or because concerns that admitting shortcomings in study design or conduct will make it difficult to get the article published. FDA reliance on journal articles as the sole basis for device approvals, as permitted under Section 2222, could prevent the FDA from learning of important problems with clinical testing, which could lead to serious patient harm.

Section 2221 would allow companies to make changes to even the highest-risk devices (like artificial heart valves) without first notifying the FDA or documenting that the modified device remains safe and effective.

2.  21st Century Cures would allow for antibiotics and antifungals to be approved based on lower FDA standards, putting patients at risk of being treated with unsafe and ineffective drugs (Section 2121).

Included in the legislation is the Antibiotic Development to Advance Patient Treatment (ADAPT) Act (Section 2121), which presents a fast-track pathway for FDA drug approval based on surrogate clinical endpoints and data from animals, test tubes, mathematical modeling and small, early-stage clinical trials in humans with diseases – rather than larger, later-stage trials. Results from clinical trials based on surrogate clinical endpoints must be confirmed with phase III trial data. Phase III trials are critical to determining the safety and effectiveness of medical treatments. Data from non-clinical trials or early, small-scale clinical trials can offer misleading evidence of efficacy or miss important safety risks.

As ADAPT provisions fail to truly address antibiotic resistance and lower FDA standards for approving antibiotics and antifungals, we have found more effective approaches to address these problems in the Helping Effective Antibiotics Last (HEAL) Act (H.R. 931), sponsored by U.S. Reps. Rosa DeLauro (D-Conn.), Louise Slaughter (D-N.Y.) and Grace Meng (D-N.Y.).

3.  21st Century Cures would weaken the reporting requirements under the Physician Payment Sunshine Act, allowing for secret influence from pharmaceutical and medical device companies on the practice of medicine and medical education (Section 3041).

Section 3041 of the bill would create an exemption under the Physician Payment Sunshine Act for drug and medical device manufacturers, allowing them to not report speaker fees or gifts to doctors that are intended for “continuing medical education” purposes, regardless of cost. Speaking fees can be a lucrative source of income for physicians, and under the bill, gifts intended for medical education may include lavish items, such as admission to an expensive conference at a fancy resort, as long as the gifts are represented as intended for medical education. An additional provision would exempt expensive medical textbooks and journals from reporting requirements by classifying them as “educational materials that directly benefit patients.” These gifts should be reported under the Physician Payment Sunshine Act.

4.  21st Century Cures would hasten the rise of resistant superbugs by incentivizing hospitals to use new antibiotics rather than conserving them for appropriate use (Section 2123).

Section 2123 of the bill would give hospitals a Medicare reimbursement incentive to use new antibiotics. Such a provision would encourage the overuse of antibiotics by giving hospitals a financial bonus each time these drugs were prescribed, rather than encouraging hospitals to use older, effective antibiotics before using new ones that may not be medically necessary. This practice would only speed the rise of antibiotic-resistant infections, as bacteria will increasingly become resistant to these new drugs as they are used more often.

5.  21st Century Cures would bar generic entry of medicines into the market for a longer period and would deny patients access to affordable, life-saving medicines (Section 2151).

Section 2151 provides an additional six months of exclusivity in addition to a drug’s existing exclusivity period if a new “orphan” indication is approved that involves treatment of a rare disease. This provision would extend the exclusivity period for all conditions the drug is designed to treat, not just the rare condition, thereby increasing health care costs and limiting patient access to new drugs for a potentially broad range of diseases.

This bill has an ambitious timeline – Republican leadership in Congress is aiming to enact it into law by the end of the calendar year.

As the 21st Century Cures Act nears a critical floor vote in the House and a companion piece of legislation is being developed in the Senate, it is vital that the American public understand the harmful provisions of this bill.

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