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Earlier this week, the House Energy and Commerce Committee released a draft of an ambitious new bill, the 21st Century Cures Act. The legislation, if enacted, would radically alter the way in which drugs and devices are regulated in the US. Within the 393-page legislation are dozens and dozens of proposals, large and small.
But which ones are especially worth paying attention to? We're glad you asked. What follows is our analysis of which proposals are likely to attract the most attention—and controversy—in the coming months.
Read our entire analysis of the bill in our 21st Century Cures Act explainer here.
Right now, most new drugs are protected from generic competition for either five years (new chemical drugs), seven years (for rare disease drugs) or 12 years (for new biological medicines).
If Section 1222 of the legislation comes into effect, most drugs—those intended for "unmet medical needs"—would get protection from generic competition for 15 years.
The goal of legislators, they explained, is to promote more investment into "new cures for patients" by making it more likely that a drug manufacturer will be able to recoup its investments.
Given President Barack Obama's previous opposition to 12 years of marketing exclusivity for new biologics (passed under the Patient Protection and Affordable Care Act), expect this to be one provision that gets a lot of attention from legislators and the generic pharmaceutical industry.
Another section, Section 1241, would also extend marketing exclusivity for many follow-on drugs. These types of drugs are ordinarily given just three years of exclusivity by FDA since they don't meet the legal definition of a "new" drug. However, under the Cures Act, many of them would be eligible for an additional two years of protection from generic competition if they meet any of five criteria:
Section 1041 of the Cures Act would permit the US Food and Drug Administration (FDA) to approve drugs it has designated as "breakthrough therapies" much sooner than in the status quo. The "breakthrough therapies" designation, established in 2012 under the Food and Drug Administration Safety and Innovation Act, is now used as a way to accelerate the review of drugs by giving a sponsor more access to FDA staff.
By contrast, the changes to the breakthrough designation program called for in the Cures Act would call on FDA to approve breakthrough therapies for "serious or life-threatening diseases or conditions" as long as an application is backed by "early state clinical safety and effectiveness data."
A drug sponsor would then need to conduct post-approval studies to obtain data indicating if a drug is in fact as effective and safe as it first appeared. FDA, meanwhile, would need to consider "the risks and benefits of the drug" in balance with the "risks associated [with the] disease or condition for which unmet medical needs exist."
In other words: FDA would be given an additional way to approve new therapies much more quickly. Whether or not it chooses to use that authority, however, is another matter entirely. The agency could be hesitant to use the authority given the lack of evidence for some drugs that have not yet undergone late-stage testing.
Section 1061 of the Cures Act would establish a new way for FDA to approve antibiotic therapies.
FDA would be tasked with setting up a "limited population pathway" for antibacterial and antifungal drugs which, if approved, would be labeled with a statement that it is only intended to be used in a "limited and specific population of patients."
The hope is that FDA can increase the number of antibiotics it approves to help combat drug-resistant bacteria, while at the same time ensuring that new products are used only in populations of patients for which the benefit of the drug is known.
For years, drugmakers have been able to sell and redeem special vouchers ("priority review vouchers") in order to get their drugs reviewed more quickly by FDA—for a price.
Now under Section 1063 of the Cures Act, companies which have an approved drug with an added five years of so-called "qualified infectious disease product" (QIDP) exclusivity will be able to sell up to one year of that exclusivity to another company.
Companies can purchase this transferrable year of exclusivity so long as they have at least four years of marketing exclusivity left, meaning companies with new drugs expected to become blockbusters might pay quite a lot of money to ensure their drugs are immune from generic competition for an additional year.
The bill states that only up to one year of exclusivity can be sold, meaning some companies might also sell several smaller blocks of exclusivity—say, six-month increments—to multiple buyers.
Section 1081 of the Cures Act instructs FDA to set up a process to review medical devices representing "breakthrough technologies" more quickly.
Such devices are those "intended to treat conditions "for which no approved alternative exist," offer "significant advantages over existing approved or cleared alternative," are "otherwise in the best interest of patients" and/or have the potential to "reduce or eliminate the need for hospitalization, improve patient quality of life."
The provisions, which mirror FDA's breakthrough therapies program for drugs, could result in quicker approvals for some medical devices.
If you turn on your TV, you probably see quite a few advertisements for new drugs. If you use Twitter, however, you probably haven't. The reason for that is FDA's restrictions on how the platform can be used. On TV, ads must present a "fair balance" between a product's risks and benefits, devoting equal time and attention to both. That's hard to do on twitter, which limits users to fewer than 160 characters per "tweet."
The Cures Act (Section 1161) would make it easier for companies to use Twitter, Facebook and other internet platforms by requiring FDA to allow companies to connect consumers with risk information through links, and not necessarily through words.
For example, you might soon see a tweet reading: "[Drug Name] was just approved by FDA for [disease]. Find out more about this drug on our website: (Link)."
For several years, Republican legislators have been trying to pass new legislation meant to clarify which types of medical software—including apps—FDA can regulate, and which types it can't regulate. Previous iterations of these bills have generally died in committee, but the Cures Act resurrects one—the SOFTWARE Act—to take yet another stab at it.
This time legislators make two new definitions of software: "Medical software" and "health software." The former type of software could be regulated by FDA, while the former type could not.
American generic drugmakers might not like several provisions of the bill—the ones staving off generic drug competition, for example—but the bill includes one sweetener some of the industry might enjoy.
The legislative language contained in Section 5051 would allow generic drug manufacturers to have their drugs designated as "American-manufactured." If that drug was the first generic product ("first-to-file") to come to market, it would then be eligible for an additional period of market exclusivity during which time no other generic product could compete with it.
That might be good news for American manufacturing, but bad news for American consumers, who would have to wait even more time to access cheaper generic drugs (first generics usually aren't as cheap as subsequent versions for various reasons).
Legislators are eyeing an upgrade to the security of the medical device supply chain in Section 5081 of the Cures Act. The Device Distribution Licensing Act of 2015 would, much like the Drug Supply Chain Security Act (DSCSA), create standards controlling which entities could even be involved in the sale and purchase of medical devices.
The law also creates provisions meant to require companies to alert FDA to any counterfeit, misbranded or nonconforming devices in their possession.
There are plenty more must-read elements of this bill that we don't have time to cover here. For a complete rundown of the bill, check out our Regulatory Explainer on the 21st Century Cures Act.
Tags: 21st Century Cures Act, 21st Century Cures Initiative, House, Congress, Legislation