Fairness in Orphan Drug Exclusivity Act

Floor Speech

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

Madam Speaker, I rise today in support of the Fairness in Orphan Drug Exclusivity Act.

The Orphan Drug Act was enacted to incentivize the development of drugs for rare diseases by giving products that receive an orphan drug designation 7 years of market exclusivity, meaning a drug produced by another manufacturer that contains the same active ingredient to treat the same condition is barred from entering the market during this time.

One way a drug can receive an orphan designation and, subsequently, market exclusivity is by the manufacturer's demonstration that there is no reasonable expectation that the cost of developing the drug will be recovered. However, we have seen in recent years that some drug manufacturers, in an effort to block competitors from the market, have tried to take advantage of a loophole in the law. Existing law allows an orphan drug designation and market exclusivity to carry forward to future versions of the same drug without requiring the manufacturer to demonstrate that the drug has not been, and remains unlikely to be, profitable.

This legislation will close that loophole, requiring manufacturers to show there is no reasonable expectation that the cost of research and development will be covered for each successor drug, while still preserving incentives for orphan drug development.

We must preserve incentives to innovate while preventing bad actors from exploiting those incentives to benefit from a national crisis, as we saw during the opioid epidemic.

While no drug currently benefits from market exclusivity awarded through this mechanism, I remain concerned about including language that allows for the retroactive revocation of an incentive through legislation.

Legislation that sets a precedent of revoking a benefit awarded prior to enactment creates a slippery slope and could chill innovation if adopted elsewhere in statute. While this bill itself is narrowly tailored, we do not want uncertainty caused by Congress retroactively legislating to discourage truly innovative drugs from coming to the market, especially for the rare disease community.

However, I will support this bill as it moves forward today as I believe it is important to prevent the abuse of this program in the future. I look forward to continuing discussions to come to a resolution on this outstanding concern as we work with the Senate to get this bill to the President's desk.

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

Madam Speaker, it is so important that we have the Orphan Drug Act. We have so many people who have rare diseases come to our offices and visit us on Capitol Hill, as they should. Hopefully we will be able to do that again soon. It just touches your heart. Many of these diseases have so few people affected by it; but if it is you or your child or somebody in your family, it is devastating.

We have all seen the power of the private marketplace to come in and produce these pharmaceuticals that make a difference. So we have to have provisions to allow these drugs to come into the marketplace and incentivize that private innovation moving forward.

But when people use that in order to move forward, this loophole has to be closed. I am glad that it is here, and it is these things that we need to work on. It is really not specifically here; it is just maybe a slippery slope in other places as we move forward.

I thank my friend from Pennsylvania for bringing this forward, and the Energy and Commerce Committee for addressing this, because we have to preserve orphan drug status for those afflicted by the rarest and the most devastating diseases. We also need to bring lower drug prices to Americans, and we can do that working together.

Madam Speaker, I appreciate this being brought forward. I urge my colleagues to support this piece of legislation, and I yield back the balance of my time.

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Mr. GUTHRIE. Madam Speaker, on that I demand the yeas and nays.

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