When it comes to faster access to drugs, first do no harm

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Over 60 percent of Americans want the government to take action to lower prescription drug prices — and Congress, for once, is listening to voters.

Lawmakers are pushing forward two pieces of parallel legislation, the Senate’s Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and another House bill the Fair Access for Safe and Timely (FAST) Generics Act of 2017.

{mosads} Both aim to provide a series of new legal provisions will make it easier for drug companies to introduce generic alternatives, thus spurring competition and bringing down prices. Both are well intentioned. Unfortunately, they’re worded poorly – leading to dangerous unintended consequences. Instead of bringing generics to market sooner, these bills could endanger patients’ lives and encourage costly, needless litigation.


To protect consumers, the Food and Drug Administration requires that new drugs undergo a series of clinical trials to prove their safety and effectiveness before entering the market. Generic drugs must also complete clinical trials, but only to prove they’re clinically equivalent to the already-approved brand-name drug. The generic drug creation process inherently requires that manufacturers obtain brand-name drug samples from innovators for comparative testing.

Some drugs are so potent, or have such dangerous side effects, that the FDA requires drug companies to develop and abide by specialized safety protocols called “risk evaluation and mitigation strategies,” when selling or dispensing these medicines.

Here’s where it gets complicated. Generic drug companies are accusing brand-name manufacturers of dragging out negotiations regarding these risk evaluation and mitigation strategies to avoid handing over drug samples. Without the samples for comparative testing, generic manufacturers can’t enter the market. And without competition, the brand-name manufacturers get to keep selling their medicines at inflated prices, even after the patent has expired.

That’s why some in Congress want to pass the CREATES and FAST acts. Both bills would allow generic drug manufacturers to sue brand-name manufacturers if they fail to hand over their drug samples for testing within 31 days, or if the companies do not reach an agreement on shared risk evaluation and mitigation strategies for risky drugs.

That sounds reasonable. Nobody wants brand-name companies to drag their feet and keep prices higher longer than necessary. But CREATES and FAST language is so imprecise that they could lead to potent medicines falling into the wrong hands, without adequate safeguards for patients.

The bills strip the FDA of its watchdog role. Under their proposals, generic manufacturers aren’t required to outline testing and safety protocols for the FDA to approve. Even if a generic drug maker’s proposed risk evaluation and mitigation strategies are inadequate, the FDA has no authority to reject or halt the transfer of medicines to the generic company for testing.

The experts at the FDA would have no choice but to approve the transfer within 90 days, even if they think doing so would put patients in danger. The CREATES and FAST acts would be a trial lawyer’s dream come true.

Poorly worded liability provisions subject innovators to unfair legal risk. Generic drug companies often obtain brand-name drug samples and ship them off to third-party research firms to perform clinical trials. If the third party is negligent with the samples, patients could get hurt. Under the bill’s terms, patients would be able to sue the brand-name drug company, even though it had no control over the testing or safety protocols.

The bills also let generic drug companies sue innovators for not handing over samples within 31 days of a request, even if both companies are actively negotiating the terms of the sample distribution and safety protocols.

Both pieces of legislation require innovators and generic companies to strike transfer deals on “commercially reasonable market-based terms,” the law doesn’t clarify what that means. Such subjective wording is music to trial lawyers’ ears.

Both houses of Congress deserve praise for trying to bring generic medicines to market faster, relieving consumers from high drug prices. Yet good intentions don’t change the fact that the CREATES and FAST acts, as currently constructed — are deeply flawed.

Congress could help consumers by reworking the legislative language to end bad behavior without gutting safeguards for patients or enabling unscrupulous trial lawyers to file costly, pointless suits. Whether it’s the practice of medicine or the development of public healthcare policy one rule applies – first do no harm.

Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest. Follow him on Twitter @PeterPitts.

 The views expressed by contributors are their own and are not the views of The Hill.

Tags Abbreviated New Drug Application Drugs FDA Food and Drug Administration Generic drug generics Healthcare Pharmaceutical drug Pharmaceutical industry Pharmaceuticals policy Pharmacy Prescription costs Prescription drug Prescription drug prices in the United States

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