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house Bill H.R. 1503

Should the FDA’s ‘Orange Book’ of Approved Drug Patents Be Improved to Promote Competition?

Argument in favor

The Orange Book is an important resource for generic drug development. Generic drugs offer lower prices to consumers, and should be supported by the federal government through initiatives such as the Orange Book.

Kodiwodi's Opinion
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05/08/2019
A bit of competition from the generic companies might inspire Big Pharma to get its prices in line with what we can afford, even if it means cutting CEO’s outrageous compensation. I support this.
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DrCindyBean's Opinion
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05/08/2019
Yes. The orange book on patents on prescription drugs must be kept up to date and made to work for the people- as well as for drug companies. The companies should not be allowed weaponize the orange book to artificial screw people over on drug prices.
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Leslie's Opinion
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05/08/2019
I'm all for anything to bring down the SKYROCKETING price of drugs. A Democratic introduced this Bill, so I am praying that this will streamline the entire process. Why it would take a year to go thru these patents is beyond me. Out here in the Real World things move at a much more rapid pace.
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Argument opposed

The patent invalidation process can be lengthy if the patent holder appeals, so keeping the Orange Book current may prove difficult. This bill could harm innovation in the pharmaceutical and medical device industries by empowering generic manufacturers.

Christian's Opinion
···
05/08/2019
I probably sound like a broken record at this point but, I will always be for less government. The least amount we need to still function. Any kind of added red tape will slow down even further the development of generics. The FDA already moves at a glacial pace. It doesn't need anything slowing it down.
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Jim2423's Opinion
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05/08/2019
It is another government buy off. Creating another law to create another government agency. We already have the FDA who can not keep up with new medicines or food inspections. Yes we need to get costs down but creating more government is not the answer. It stop lobbying and pharmaceuticals paying into congress campaign funds.
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cpreston2's Opinion
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05/08/2019
The discussion of invalidating patents concerns me. Could this bill lead to invalidating patents so generics manufacturers could bring competing products to market sooner?
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bill Progress


  • Not enacted
    The President has not signed this bill
  • The senate has not voted
      senate Committees
      Committee on Health, Education, Labor, and Pensions
  • The house Passed May 8th, 2019
    Roll Call Vote 422 Yea / 0 Nay

    Your Representative Voted

    Rep Harris
    Voted yea
      house Committees
      Committee on Energy and Commerce
      Health
    IntroducedMarch 5th, 2019

Log in or create an account to see how your Reps voted!

What is House Bill H.R. 1503?

This bill — the Orange Book Transparency Act of 2019 —  would increase access to lower-cost generic drugs and bolster competition within the generic drug marketplace to help reduce drug costs by ensuring that patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (aka the Orange Book) are valid and relevant to the approved product. It’d also strengthen requirements surrounding the removal of invalidated patents from the Orange Book.

Specifically, this bill would:

  • Clarify the types of patents listed in the Orange Book (and require the removal of invalidated patents);
  • Require a list of applicable exclusivities for listed drugs;
  • Create a private-sector mandate requiring drug manufacturers to promptly submit a patent withdrawal or removal to the FDA for patents found invalid by the Patent Trial and Appeals Board or another court; and
  • Empower the FDA to: 1) add additional patents to the Orange Book if necessary, 2) promptly remove patents from the Orange Book which are found to be invalid, and 3) reconsider the types of patents listed in the Orange Book within one year of enactment.

This bill would also clarify that device patents aren’t required to be listed in the Orange Book, but should still be shared with the FDA to prevent efforts to delay generic drug competition based on the delivery mechanism.

This bill would also require the FDA to solicit public comments regarding the types of patient information to be listed in the Orange Book. Within a year of this bill’s enactment, the FDA would then give Congress an evaluation of such comments, including any recommendations about the types of patent information that should be included in or removed from the Orange Book.

This bill would also direct the Government Accountability Office (GAO) to conduct a study that analyzes certain patents with claims relating to devices listed in the Orange Book, and evaluates the extent to which listing such patents have affected the timing for the entry of generic drugs into the market. A report of the GAO’s findings would be due to Congress within a year of this bill’s enactment.

The Orange Book is a list of drug products approved by the FDA under the Federal Food, Drug, and Cosmetic Act that includes patent and exclusivity information and identifies whether a drug is currently being marketed or has been discontinued.

Impact

Pharmaceutical companies; pharmaceutical drug development; generic drug development; the FDA; GAO; and the Approved Drug Products with Therapeutic Equivalence Evaluations Publication (Orange Book).

Cost of House Bill H.R. 1503

$1.00 Million
The CBO estimates that implementing this bill would cost $1 million, primarily for the FDA’s personnel-related expenses to comply with this bill’s reporting requirements.

More Information

In-DepthRep. Robin Kelly (D-IL) introduced this bill to increase access to lower cost generic drugs and bolster competition in the marketplace to drive down prescription drug costs for American families:

“No one should be forced to choose between lifesaving medicine and putting food on the table. Sadly, this is the everyday reality of too many people. There is more that we can and should do to lower drug costs for American families. This bill will increase access to and competition from generic drugs. The result will be lower out-of-pocket costs for families – a major promise of Democrats’ For the People agenda.”

In a January 2019 press release, the FDA expressed support for making the generics industry “as competitive as possible” to ensure consumers have access to affordable medicines. In the service of this goal, FDA Commissioner Scott Gottlieb acknowledged the importance of an updated Orange Book:

“Maintaining an up-to-date Orange Book also serves many important public health roles. Among its many benefits, the Orange Book helps keep health care providers informed on what drugs are approved and available.”

In testimony to the House Energy and Commerce Health Subcommittee, Association for Accessible Medicines (AAM) president and CEO Chester “Chip” Davis, Jr. expressed his organization’s support for this bill:

"AAM supports the Orange Book Transparency Act and the Purple Book Continuity Act, and recommends additional transparency and disclosure requirements consistent with our comment letter to HHS be included… Efforts to ensure patients are able to fully realize the savings available from generic and biosimilar medicines on the market today combined with Congressional action to advance policies that increase competition is the ultimate equation to achieving the shared goal of enhancing patient access to more affordable generic and biosimilar medicines."

In a House Energy and Commerce hearing on this and other bills, including the Purple Book Continuity Act of 2019, Republican leadership raised the concern that lowering drug costs had become a one-sided issue, as Democrats kept them in the dark on bill language and witness attendance. Republicans contended that many of the bills before the subcommittee lacked bipartisan support due to short notice, and that some of the proposed legislation even made complex changes to the FDA without the agency’s input or attendance at the hearing. Republicans and several witnesses expressed concern that legislation discussed would stifle innovation. Witnesses testified that settlements between branded and generic manufacturers get generic products to market more quickly than requiring parties to pursue the full litigation process. In response, Democrats continuously stressed than more generic competition was needed to immediately lower prices, and many encouraged greater biosimilar market entry and uptake.

In the House Energy and Commerce Committee hearing, Jeff Kushan, Sidley Austin LLP partner, also warned that it would be tedious to update the Orange Book constantly when many of the patents found to be invalid go through several appeals before a final decision.

This bill passed the House Energy and Commerce Committee by a voice vote with the support of 13 bipartisan cosponsors, including 12 Democrats and one Republican.


Of NoteThe Orange Book is an important tool for the development and prescribing of generic drugs. Doctors and pharmacists use the Orange Book for information on generic drug approvals and availability. Likewise, generic companies use the Orange Book to make critical R&D decisions. Experts, medical professional and advocates have been suggesting Orange Book improvements for many years.

In January 2019, the FDA announced a number of initiatives to improve the Orange Book. These include: new draft guidance for approved drug application holders clarifying the specific categories and descriptions of the information they’re required to give the FDA on the marketing status for their brand and generic drugs and how to provide it in a timely and consistent manner; new draft guidance describing how the FDA evaluates therapeutic equivalence (TE) and assigns therapeutic equivalence codes; and new draft guidance to help drug product applicants and approved application holders in using the Orange Book.


Media:

Summary by Lorelei Yang

(Photo Credit: iStockphoto.com / Anawat_s)

AKA

Orange Book Transparency Act of 2019

Official Title

To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes.

    A bit of competition from the generic companies might inspire Big Pharma to get its prices in line with what we can afford, even if it means cutting CEO’s outrageous compensation. I support this.
    Like (53)
    Follow
    Share
    I probably sound like a broken record at this point but, I will always be for less government. The least amount we need to still function. Any kind of added red tape will slow down even further the development of generics. The FDA already moves at a glacial pace. It doesn't need anything slowing it down.
    Like (10)
    Follow
    Share
    Yes. The orange book on patents on prescription drugs must be kept up to date and made to work for the people- as well as for drug companies. The companies should not be allowed weaponize the orange book to artificial screw people over on drug prices.
    Like (22)
    Follow
    Share
    I'm all for anything to bring down the SKYROCKETING price of drugs. A Democratic introduced this Bill, so I am praying that this will streamline the entire process. Why it would take a year to go thru these patents is beyond me. Out here in the Real World things move at a much more rapid pace.
    Like (17)
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    Share
    Big pharma has chased off competition to save their inflated drug prices for too long. Back 2001, pharmaceutical companies tried to keep generic AIDS from being sold to poor countries who couldn’t afford the more expensive drugs. How selfish. And these companies will say that they are “helping” people? Please review this article: https://www.nytimes.com/2001/06/26/world/us-drops-case-over-aids-drugs-in-brazil.html
    Like (16)
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    We must lower the cost of healthcare
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    We should also stop the patenting of drugs developed by public sector funding.
    Like (9)
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    As a retired RN and family therapist, I reluctantly support this bill. My clinical experience is that generic drugs don’t always work as well as the original name brand, perhaps because a single element is so important or because of being produced with less stringent oversight or more quickly when profit is decreased. Life saving drugs/meds should be available to those who need them. I’d want this option for needed drugs I couldn’t afford rather than no opt ion.
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    Another NO BRAINER. YES.
    Like (8)
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    The Orange Book is an important resource for generic drug development. Generic drugs offer lower prices to consumers, and should be supported by the federal government through initiatives such as the Orange Book. Republicans should not have been frozen out of making this bill.
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    Competition is good for lower prices
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    I agree with anything that will lower drug prices. People should not have to choose between food and life saving medication. There has to be a provision that stat that if a generic does not work as well ass the name brand, people can still aces it. Another way to lower prices is to stop the lobbyists. They pay congress big money to stop things like this
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    Yes to HR-1503! The FDA’s ‘Orange Book’ of Approved Drug Patents must Be Improved to Promote Competition. However, we must have Medicare for all which would allow the government to negotiate the lowest prices on a mass scale to reduce the cost of Health Care in our nation! This will lead to an increase living wage employment in our nation by reducing the cost of Labor and eliminating for profit Healthcare insurance's exorbitant costs❗🗽
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    Drugs that are going off patent should not have protections. Period. Their formulations should become public and competition should be encouraged. As is, the pharma industry does everything it can to discourage competition and raise drug prices beyond ethical and legal boundaries. So, as an industry, their protestations should hold little legal or public sympathy.
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    The discussion of invalidating patents concerns me. Could this bill lead to invalidating patents so generics manufacturers could bring competing products to market sooner?
    Like (4)
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    If other countries, such as Canada, can provide universal health care and legal, non-addictive, alternative herbal pain re-LEAF 🍃😉.... the least our country can do is push legislation that decreases the socioeconomic gap between those that can afford medication and those who cannot.
    Like (4)
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    Competition is part of how we lower health care costs.
    Like (4)
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    It is another government buy off. Creating another law to create another government agency. We already have the FDA who can not keep up with new medicines or food inspections. Yes we need to get costs down but creating more government is not the answer. It stop lobbying and pharmaceuticals paying into congress campaign funds.
    Like (4)
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    Finally, something in congress to take a small step toward medicine cost reduction. Now go Bi-Partisan and fix tort reform, medicare prescription negotiations with drug companies and force insurance companies in ACA offer throughout all of NC ( not just cherry pick markets)!
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    Competition and being able to get insurance across state lines will also reduce the cost of healthcare
    Like (3)
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