In Vermont, Iowa, and every other state across the country, people are fed up with the high cost of prescription drugs. Prices continue to skyrocket as companies making brand-name drugs restrict competition by refusing to share samples of their drugs with companies aiming to make generic versions or refusing to negotiate a shared safety protocol. This is an abuse of government regulations that are intended to protect patients and ensure drug safety.

These practices punish patients and worsen illnesses. Families, businesses, government programs, and other payers in the health care system must bear the added, unnecessary costs that accrue when a generic is shut out.

Lawmakers across the political spectrum, including President Trump, agree that Congress needs to act to rein in spiraling prescription drug prices. We can start by cracking down on abuses by companies making brand-name drugs that engage in tactics to artificially delay the development of generic alternatives. These stifle competition and keep prices artificially high. It is no wonder that hardworking Americans feel like the system is rigged against them by corporations that are seizing any opportunity unfairly restrict competition and reap monopoly profits long after patents expire.

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Some — not all — companies that make brand-name drugs limit release of their products to prevent access to samples as a way to delay the development of generic versions. These tactics block more-affordable FDA-approved generics that save patients — and taxpayers — money at the pharmacy counter. When a generic manufacturer is not able to buy drug samples, it is impossible to do the careful testing that’s needed to ask the Food and Drug Administration to approve the medication. FDA Commissioner Scott Gottlieb has rightly called these tactics “unfair and exploitative” and “in direct conflict to our broader public health goals.”

Cancer patient David Mitchell testified before Congress about one company’s efforts to deny a generic company’s access to samples of Revlimid, a lifesaving cancer treatment. Access to samples of the drug has been at issue since 2009. If it were not for this ongoing abuse of the FDA’s safety programs, a generic alternative could be available to David and other patients as early as next year.

Because there is no generic alternative, the cost of Revlimid has remained artificially high and has actually risen fourteen times since this abuse began, from $9,853 in 2010 to its current price of $18,546 for a 28-count bottle. This is just one example out of more than 150 complaints that the FDA has received from generic manufacturers.

To end these anti-competitive tactics, a bipartisan coalition of lawmakers — including Republican Sens. Mike Lee (Utah), Ted Cruz (Texas), Rand Paul (Ky.), and Democratic Sens. Amy Klobuchar (Minn.), Dianne Feinstein (Calif.), and Dick Durbin (Ill.) — have joined us to introduce the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. This bill is supported by a broad and politically diverse coalition of 68 organizations representing hospitals, physicians, patients, employers, and unions. AARP, Families USA, FreedomWorks, and Heritage, to name just a few, have endorsed this common-sense legislation. The public also agrees: Recent polls show that 84 percent of Americans support the CREATES Act.

Our bipartisan bill targets anti-competitive behavior that keeps prices artificially high, such as when companies withhold drug samples from generic manufacturers or refuse to negotiate a shared safety protocol. Both steps undermine the FDA approval process and block potential generic competitors from creating less-expensive alternatives.

Companies making brand-name drugs that stand in the way of the CREATES Act wrongly claim the legislation will lead to frivolous lawsuits. This is a red herring. Our bill is narrowly tailored and would only allow eligible product developers seeking to develop a medicine to sue, only after receiving FDA authorization. Trial lawyers will have no standing to sue under our plan.

Another baseless argument we have heard is that counterfeit product developers who do not intend to develop a drug will take advantage of the CREATES Act in order to seeks damages from a brand-name company. Wrong again. Under the CREATES Act, court challenges are only allowed based on continued delays after the FDA has certified the safety and the brand has refused to release samples. The significant costs to submit protocols to the FDA also discourages this behavior. These arguments do not hold up against the clear and limited remedies available under the CREATES Act.

Conservatives who support the CREATES Act appreciate that it lowers drug costs by quickly bringing parties to the negotiation table under the threat of litigation instead of a drawn-out regulatory action. The act is not a drastic measure, but allows the generic development process to proceed as intended by Congress under the Hatch-Waxman Act. Companies making brand-name pharmaceuticals need only to negotiate in good faith and provide the samples for testing on market terms to avoid a lawsuit.

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This bill offers Congress an opportunity to take meaningful action to lower the cost of prescription drugs. It would save $3.8 billion in federal spending over the next 10 years and many billions more in costs to consumers.

The CREATES Act is a sensible, efficient, market-based way for generic drug manufacturers to address the delays in developing generics without jeopardizing patient safety or creating lengthy battles in the courts. There is no question that pharmaceutical companies should be compensated for their important work developing lifesaving treatments. But they should not be allowed to use predatory practices to cling to their patents and delay the development of generics at the expense of their customers.

Congress has a straightforward and fully bipartisan chance to actually do something to wind down the upward spiral of drug prices. Enough talk. It’s time for real action.

Democratic Sen. Patrick Leahy represents the state of Vermont. Republican Sen. Chuck Grassley represents the state of Iowa.

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  • This bill was introduced almost a year ago and seems to have made no progress. Not sure why the Senators seem so upbeat about it.

  • The brand name producer of a drug was developed by them at their own expense, further, if the drug research does not yield a useful drug, then it is a financial loss. Then, when they finally get a useful, effective drug which saves lives, they get a patent on it so they can recover their losses and make a profit. All generic companies do is wait to get the formula and start making the drug with little overhead expenses. It’s like asking for something for nothing! If there were no brand name companies, you would never any new drugs for diseases that have no or poor treatments. No new effective drugs for diseases that have no cure, means you get that disease and you just suffer (or die). If the government prohibits them from charging enough to make a profit, they stop making new drugs and become a generic company like all the rest. Be Careful What You Ask For!!!!

    • And what about taxpayer funded university research creating new drugs which are then licensed by big pharma for big profits at the expense of the taxpayers who funded the research? These also cost huge sums and often fail but pharma gets to cherry pick the winners and taxpayers take the losses on both ends…..The profits are often way above reason simply because of greed and political influence….seems like other countries “get new drugs” and pay much less …..and then there is always that pesty ethical issue of letting people die or ruining their lives to protect shareholders or partners interests…. Robert Clive killed literally millions of ASIANS in the 18th century justifying it as his duty to EIC shareholders….funny how some things never change….where do YOU draw the line?

  • As much as I dislike the pharmaceutical companies practices, government is already too involved in business. This is like a car company being forced to provide full design specs to a competitor for “safety” concerns. Stay out of business’ way and you will get lower costs.

    • Take out lobbyists and you might have a “business way”….crony capitalism is not capitalism.

  • I support the CREATED bill, an even more important challenge wld be to make drugs in our own country so we are not suseptible to having needed drugs held hostage in global negotiations.

  • This is a crock. Why would any pharmaceutical company spend millions to billions developing new drugs if they had to then turn them over to other companies to copy as generics? Those new drugs don’t just fall like manna from the sky.

  • Please help with diabetic medicines. Humalog and Januvia I live on social security. Also my husbands Parkinsons medicine carba/levadopa all these are very expensive when I get in the donut hole about the end of May. Thank you

  • NO!, it’s time to STOP making DRUGS!!!!!!!!!!!!!!!! Nature has the answers to replace drugs. Drugs were never meant for the HUMAN or ANIMAL body! YOU can’t survive on Drugs!!!!!!!!!!!!

    • Who said that we could survive on drugs? However, without drugs many of us would not survive at all.

    • You are a dreamer. People died from TB in past times because they did not know what caused it, let alone be able to treat it. Now it is treatable and people go on to live useful and productive lives. Otherwise, it may a case were they cannot live without the medical treatments!!!!!!!!!!!!

  • There is no free market in prescription drug sales with no equivalents. Consumers have to pay what the company demands because we do not have access to competitive products. Free markets require competition. I can choose to buy and OTC that is the brand name product, or a generic version. I cannot do so with a drug with no generic version. I am a consumer who is in favor of this bill. I admit to limited knowledge of all of the implications of the bill, but I do know something has to be done to stop continual increases in the prices of drugs that already exist, have not been changed in any way, but make a lot of money for companies that just want to gouge desperate patients. Revlimid is given as an example, but I have read of many, many more.

    • Please explain why a drug company should allow competitors to make a substitute generic drug after spending a fortune to develop new drugs.
      I’ve never heard of Revlimid; however, if the maker had not spent the money to develop it, there would not even be the possibility of a generic version somewhere down the road.

    • You are a dreamer. People died from TB in past times because they did not know what caused it, let alone be able to treat it. Now it is treatable and people go on to live useful and productive lives. Otherwise, it may a case were they cannot live without the medical treatments!!!!!!!!!!!!

  • This article is very misleading. 1) Yes, people are fed up with the high cost of health care, but we’re looking for a meaningful way to bring those costs down. The CREATES Act is not it. It only applies to a handful of drugs, many of which already have or will soon have generic equivalents. 2) Lower prices should not be a priority over patient safety. We’re talking about loosening restrictions on medications that could cause death and severe birth defects if not taken properly. 3) That poll showing that “84 percent of Americans support the CREATES Act” was funded by a biased organization that takes funding from a foundation with ties to the insurance and PBM industries. 4) This article mischaracterizes arguments that the CREATES Act would lead to frivolous lawsuits. No one is saying that trial attorneys would sue drug makers on their own accord. That’s nonsense. Trial attorneys would represent potential drug developers, including those that may not have the capacity to meet stringent safety protocols but who would lay claim to samples for bioequivalence testing regardless. 5) The article says “Another baseless argument we have heard is that counterfeit product developers who do not intend to develop a drug will take advantage of the CREATES Act in order to seeks damages from a brand-name company.” This sentence conflates several arguments against the CREATES Act. One argument is that unscrupulous parties may seek to obtain samples and then resell them on the black market. Many of the medications with REMS are controlled substances, so it’s not out of the realm of possibility. Another argument is that if the product developer is not able to meet the proper safety requirements after the product is FDA approved, the brand manufacturer can be held liable for injury to patients even if the patient is harmed by the generic drug. This is well established case law. In such a case, the brand and generic drugs could be pulled from the market, leaving patients who need these meds with no treatment. 6) True conservatives would not support the CREATES Act. They would be in favor of letting the free market do its job and allow private entities negotiate the sale of samples without government interference.

    • Nice to see such a fast response from our favorite PhRMA lobbyist! Too bad your owners are not AS fast when responding – or not responding at all – to generics’ requests for samples. And THAT is an issue for EVERY blockbuster drug, so don’t Lie and say it is only a “handful.”

    • “Concerned Consumer” seems to be parroting PhRMA/BIO. Is there a reason this comment is anonymous—indeed probably disingenuous—whereas the Senators signed their piece?

      “Let the free market do its job” Just wow. If we had a truly competitive free market, we would not be having this debate. And “without government interference.” Just wow in spades. Come on, “Concerned consumer” reveal yourself.

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