Fairness in Orphan Drug Exclusivity Act

Floor Speech

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume.

I rise in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. The legislation will close a loophole in the orphan drug program to ensure generic drugs can come to market and are not unfairly blocked by their brand competitors.

This bill, which passed the House by a voice vote last Congress, takes steps to address two crises: one, the soaring cost of prescription drugs; and, two, the ongoing opioid crisis. It deserves our bipartisan support once again today.

The Orphan Drug Act has been successful in driving research and discovery of new therapies to treat and even cure rare diseases. The law incentivizes the development of these therapies, including by awarding 7 years of market exclusivity and two pathways for manufacturers to receive these incentives.

Under the first pathway, orphan drug status may be awarded when manufacturers develop drugs approved to treat diseases with patient populations of 200,000 or fewer. Under the second pathway, through the rarely used cost recovery pathway, they may receive orphan drug status if drug research and development costs are not expected to be recouped by sales of the underlying drug.

Now, under certain circumstances, a manufacturer may also get additional rounds of exclusivity for additional drugs in their portfolio if they treat the same condition and have the same active ingredient, even if the second drug does not meet the orphan drug qualifications. This provision has allowed some manufacturers to circumvent the original intent of the Orphan Drug Act, which was to incentivize the creation of novel drugs for small populations.

Because of this loophole, some manufacturers have been able to market widely used drugs to large populations, all while retaining exclusivity and blocking generic competition from coming to market.

An example of this recently occurred when a formulation of bupe, a drug to treat opioid use disorder, was approved in 2017 and was allowed to carry the orphan drug designation granted to its manufacturer's original bupe drug more than 20 years earlier in 1994.

When the original 1994 orphan drug designation was granted, it was expected that this drug would not be prescribed frequently. However, as the opioid crisis worsened, and our response to the crisis evolved, millions were eventually prescribed the treatment, generating billions in sales.

Clearly, we knew in 2017 that bupe was not an orphan drug. Nevertheless, the drug was granted orphan drug status and exclusivity, and that delayed additional forms of generic competition.

While the FDA eventually recognized this issue with this particular drug and revoked its orphan drug designation, its exclusivity delayed generic competition that otherwise would have been on the market.

We need, Madam Speaker, every tool available to us to combat the opioid epidemic, including low-cost, affordable medication treatments, and loopholes like this one should not be allowed to limit access to low-cost drugs.

H.R. 1629 would stop this from happening again in the future. It requires drug manufacturers to demonstrate in their application to the FDA that each drug application considered under the cost recovery pathway would fail to recoup development costs. The legislation would also ensure that these rules apply to drugs already on the market.

This bill is a narrowly tailored fix for a narrow but very real loophole in the law. I thank Representative Dean from Pennsylvania for introducing this bill. It passed the House on a bipartisan basis, by voice vote, and without opposition last Congress. I look forward to it passing with bipartisan support again today and getting it through the Senate and to President Biden's desk so it can become law. I urge all of my colleagues to support the bill.

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Mr. PALLONE. Madam Speaker, I yield such time as she may consume to the gentlewoman from Pennsylvania (Ms. Dean), the author of this legislation, which is important because whenever we can encourage generics and make drugs more affordable, it is certainly to the benefit of the American people.

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Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume for the purpose of closing.

Madam Speaker, I thank Representative Guthrie for his remarks about trying to work together to lower the cost of prescription drugs. I thank Congresswoman Dean because this is a part of that effort.

As you will note, today, we had a whole package dealing with mental health, behavioral health, and other drug activities. It is very important that we move this whole package and try to get it passed in the Senate as quickly as possible.

Madam Speaker, I urge support for this legislation on a bipartisan basis, and I yield back the balance of my time.

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