Post by stcks on Apr 26, 2018 18:02:36 GMT
Drug Price Reforms Come With Expensive Side-Effects
www.investors.com/politics/commentary/drug-price-reforms-come-with-expensive-side-effects/
PETER J. PITTS
Six in 10 Americans want the federal government to reduce prescription drug prices.
Congress seems to be listening. Lawmakers are advancing two pieces of legislation to accomplish this worthwhile goal. Both bills seek to bring low-cost generic drugs to market faster, thus spurring competition and driving down prices.
Unfortunately, the bills are poorly worded. They could endanger patients' lives and encourage costly, unnecessary litigation. That may be good news for trial lawyers looking for their next big settlement windfall. But for patients hoping to save money at the pharmacist counter, neither reform is cause for celebration.
The Senate's Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and the House's Fair Access for Safe and Timely (FAST) Generics Act would undermine patient protections embedded in our drug approval system, which is the safest in the world.
Presently, the FDA requires experimental medicines to undergo a series of clinical trials. The FDA only approves the drugs if the drugs are shown to be safe and effective. Generic drugs must also complete clinical trials, but only to prove that they're clinically equivalent to their already-approved brand-name predecessors.
If a medicine is unusually potent or has especially dangerous side effects, the FDA requires drug companies to develop and adhere to specialized safety protocols when selling or dispensing the medicines. These are called "risk evaluation and mitigation strategies," or REMS.
Both bills would strip the FDA of its watchdog role. The FDA would have no authority to evaluate, approve, and monitor generic drug makers' REMS plans, even if FDA officials thought the proposed safety strategies were grossly inadequate.
The bills also contain ambiguously-worded liability provisions. These provisions would make brand-name drug makers responsible for actions they have no power to prevent, subjecting them to extraordinary legal risk.
Here's why. To prove generic drugs are equivalent to brand-name medications, generic drug makers must first obtain samples of those brand-name drugs. It's common for generic manufacturers to ship these samples to third-party research firms who have been hired to perform the clinical trials.
Under the proposed legislation, if the third-party is negligent and patients are harmed, the brand-name manufacturer — not just the third-party researcher and the generic firm — would be liable. Injured patients would be able to sue the brand-name manufacturer even though that firm has no control over the testing process.
Brand-name drug firms will see their legal fees soar, an expense that will be passed on to patients in the form of higher drug prices.
Additionally, the bills would allow generic drug manufacturers to sue if brand-name firms fail to hand over drug samples for testing within 31 days of being contacted — or if the companies don't reach an agreement about how to handle and test risky drugs.
These provisions, which are designed to stop brand-name manufacturers from stalling the development of cheaper generic drugs, seem reasonable in theory. But the actual legislative language is ambiguous. Such imprecise wording, together with the short-time limit, will give generic firms ample opportunity to bring their brand-name competitors to court.
Congress deserves praise for trying to stimulate pharmaceutical price competition. Yet good intentions don't change the fact that both bills, as currently constructed, are deeply flawed.
Lawmakers ought to rework the bills' imprecise wording to encourage competition — without gutting safeguards for patients or enabling unscrupulous trial lawyers to file costly, pointless suits.
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
www.investors.com/politics/commentary/drug-price-reforms-come-with-expensive-side-effects/
PETER J. PITTS
Six in 10 Americans want the federal government to reduce prescription drug prices.
Congress seems to be listening. Lawmakers are advancing two pieces of legislation to accomplish this worthwhile goal. Both bills seek to bring low-cost generic drugs to market faster, thus spurring competition and driving down prices.
Unfortunately, the bills are poorly worded. They could endanger patients' lives and encourage costly, unnecessary litigation. That may be good news for trial lawyers looking for their next big settlement windfall. But for patients hoping to save money at the pharmacist counter, neither reform is cause for celebration.
The Senate's Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act and the House's Fair Access for Safe and Timely (FAST) Generics Act would undermine patient protections embedded in our drug approval system, which is the safest in the world.
Presently, the FDA requires experimental medicines to undergo a series of clinical trials. The FDA only approves the drugs if the drugs are shown to be safe and effective. Generic drugs must also complete clinical trials, but only to prove that they're clinically equivalent to their already-approved brand-name predecessors.
If a medicine is unusually potent or has especially dangerous side effects, the FDA requires drug companies to develop and adhere to specialized safety protocols when selling or dispensing the medicines. These are called "risk evaluation and mitigation strategies," or REMS.
Both bills would strip the FDA of its watchdog role. The FDA would have no authority to evaluate, approve, and monitor generic drug makers' REMS plans, even if FDA officials thought the proposed safety strategies were grossly inadequate.
The bills also contain ambiguously-worded liability provisions. These provisions would make brand-name drug makers responsible for actions they have no power to prevent, subjecting them to extraordinary legal risk.
Here's why. To prove generic drugs are equivalent to brand-name medications, generic drug makers must first obtain samples of those brand-name drugs. It's common for generic manufacturers to ship these samples to third-party research firms who have been hired to perform the clinical trials.
Under the proposed legislation, if the third-party is negligent and patients are harmed, the brand-name manufacturer — not just the third-party researcher and the generic firm — would be liable. Injured patients would be able to sue the brand-name manufacturer even though that firm has no control over the testing process.
Brand-name drug firms will see their legal fees soar, an expense that will be passed on to patients in the form of higher drug prices.
Additionally, the bills would allow generic drug manufacturers to sue if brand-name firms fail to hand over drug samples for testing within 31 days of being contacted — or if the companies don't reach an agreement about how to handle and test risky drugs.
These provisions, which are designed to stop brand-name manufacturers from stalling the development of cheaper generic drugs, seem reasonable in theory. But the actual legislative language is ambiguous. Such imprecise wording, together with the short-time limit, will give generic firms ample opportunity to bring their brand-name competitors to court.
Congress deserves praise for trying to stimulate pharmaceutical price competition. Yet good intentions don't change the fact that both bills, as currently constructed, are deeply flawed.
Lawmakers ought to rework the bills' imprecise wording to encourage competition — without gutting safeguards for patients or enabling unscrupulous trial lawyers to file costly, pointless suits.
Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.
