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Facial Recognition Tech: 4 Things You Must Know

Updated June 18

On May 22 and June 4, Congress held hearings on facial recognition technology. The Congressional hearings examine the use of facial recognition technology by federal, state, and local government agencies, corporations and social media companies. Specifically, lawmakers address privacy and civil rights concerns.

Facial Recognition Tech: 4 Things You Must Know

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Click here to watch the Hearing on C-SPAN
  1. Facial recognition technology programs cannot accurately identify people of color and women.
  2. Facial recognition technology is not regulated by government.
  3. Law enforcement agencies and corporations use facial recognition technology without our consent.
  4. Facial recognition technology contributes to employment discrimination — against people over the age of 40, women and minorities — and to disparities in health insurance premiums.

All information provided is verifiable, for example: the videos and resources provided (and the sources cited in the resources provided) confirm all statements.

Facial Recognition Technology Resources

  1. Read Written Testimony: [United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) – Its Impact on our Civil Rights and Liberties by Joy Buolamwini, Founder, Algorithmic Justice League]
  2. Read Written Testimony: [United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) – Its Impact on our Civil Rights and Liberties by Professor Andrew Guthrie Ferguson, University of the District of Columbia, David A. Clarke School of Law]
  3. Read Written Testimony: [United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) – Its Impact on our Civil Rights and Liberties by Dr. Cedric Alexander, Former President, National Organization of Black Law Enforcement Executives]
  4. Read Written Testimony: [United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) – Its Impact on our Civil Rights and Liberties Ms. Clare Garvie , Senior Associate, Georgetown University Law Center, Center on Privacy & Technology]
  5. Read Written Testimony: [United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) – Its Impact on our Civil Rights and Liberties by Ms. Neema Singh Guliani, Senior Legislative Counsel, American Civil Liberties Union]

Video Resources: Facial Recognition Tech

  1. Watch Video: [ by United States House Committee on Oversight and Government Reform, Re: Facial Recognition Technology (Part 1) Its Impact on our Civil rights and Liberties on YouTube]
  2. Watch Video on C-SPAN: [The House Oversight and Reform Committee held a hearing to examine the use of facial recognition technology (Part 2) by the government and commercial entities and its impact on civil rights and liberties. Witnesses discussed the flaws in the technology, including programs that could not accurately identify people of color and women. Other concerns raised were the lack of regulation and oversight in the technology, how law enforcement is using facial recognition, fears of racial profiling, and the privacy issues surrounding Facebook, Uber, and Amazon’s use of the technology]

About the Author

Olivia P. Walker is an award winning public affairs and administration professional. She launched O.W.B Public Affairs and writes all site content. She previously consulted for the International Society of Pharmaceutical Engineering and served as government affairs and public policy analyst at WellCare Health Plans.  Olivia is a fusion belly dancer and a member of the American Society for Public Affairs and Administration’s section on public law and administration.

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Treason or Hypocrisy? Pick your Poison, Re:Featured image for Midterm Elections 2018: Treason or Hypocrisy, Pick your Poison.

Commentary: Midterm Elections 2018, Treason or Hypocrisy? Pick Your Poison

Midterm Elections 2018: Treason or Hypocrisy?

Do you prefer treason or hypocrisy? This is a question many Americans will answer when voting in the 2018 midterm elections. Personally, I’m struggling; I’m keenly aware of what’s at stake here. I voted. But here’s the deal, I don’t give away votes.

The Democratic Party

There are serious problems in the Democratic party, the party:

  • Fails — abysmally — to meaningfully act on behalf of the poor and people of color.
    • As a bi-racial millennial woman, I need to remind the Democratic Party: We are NOT your pawns.
  • Needs to grow some balls — the holier than thou approach is ineffective and condescending.
  • Fails to acknowledge the hypocrisy permeating the Party.
  • Must stop suggesting ‘racism’ is unique to republicans.
    • While some republicans are racists, so too are some democrats.
    • Racism is alive and well in both Parties.

[WellCare Health Plans Paid For My Silence]

Trump’s Republican Party

There are profoundly disturbing facts about Trump’s Republican party, the party:

  • Consistently violates laws and administrative codes of ethics.
  • Engages is blatant racist, bigoted and divisive rhetoric (among other things).
  • Lies, cheats and uses deceptive practices.
    • To be clear, the lies and deceptive practices will — irreparably — harm many republicans (and people in general). It will however, take time to realize their detrimental impact.
  • Russia…Enough said.
  • Has taken — quantifiable —action to prevent Native Americans, poor people, African-Americans, and other social groups from voting (which is a right of American citizenship, with some exceptions).

[Watch O.W.B Videos Online]

Key Takeaway

With regard to America’s electoral system and democratic processes, They are not sustainable and certainly not ideal. Elections and government actions have consequences. Americans deserve better because the decisions made by government officials impact the realities we face everyday.

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About the Author

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Olivia P. Walker is a public affairs strategist, campaign consultant, and writer. She launched O.W.B Public Affairs Digest in 2017.  Most recently, Olivia served as governance consultant for the International Society for Pharmaceutical Engineering.  Prior to these roles, Olivia worked as government affairs and public policy analyst for WellCare Health Plans, a Fortune 500 health insurer.

[Congress Proposed Change to Constitution]

Olivia holds a master’s degree in public administration from the University of South Florida School of Public Affairs. In 2016, Olivia was duly initiated into Pi Alpha Alpha, the Global Honor Society for Public Affairs and Administration. She is a member of the American Society for Public Administration and a member of the ASPA Section on Public Law and Administration. Olivia also holds a Graduate Certificate in Globalization Studies. The certificate is a specialized graduate-level credential reflecting knowledge of the most up-to-date research on globalization.


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FDA approves Generic Drug Under New Approval Pathway post featured image.

FDA Approves First Generic Drug Under New Approval Pathway

 

The Food and Drug Administration (FDA) approved the first generic drug under a new approval pathway today.

FDA Approves First Generic Drug Under New Approval Pathway

The FDA granted approval of potassium chloride oral solution USP to Apotex Inc., a global pharmaceutical company that produces both generic and novel drugs. Potassium chloride is an oral treatment for patients at risk for low potassium blood levels. Importantly, the products approved today are the first generics to receive a Competitive Generic Therapy (CGT) designation. Also notable, the drug application received approval during the first review cycle.  The following two potassium chloride oral solutions are approved:

  1. Potassium chloride oral solution USP, 10% (20 mEq/15 mL) and
  2. Potassium chloride oral solution USP,20% (40 mEq/15 mL).

What is a Competitive Generic Therapy Designation?

The Reauthorization Act of 2017 gives the FDA authority to name a drug as a Competitive Generic Therapy if there is inadequate generic competition for that drug. The CGT  designation is a new drug approval pathway. The FDA’s use of CGT is a strategy to speed up the development and review of generic drug products.  Further, the aim of CGT is increasing competition in the generic drug market.

Inadequate Generic Competition

Inadequate generic competition means ‘that not more than one approved drug in the active section of the publication Approved Drug Products with Therapeutic Equivalence Evaluations’ exists. The Approved Drug Products with Therapeutic Equivalence Evaluations publication is popularly called the Orange Book. The Orange Book identifies drug products approved by the FDA based on safety and effectiveness.

 

Generic Drug Prices Photo inserted into FDA post on O.W.B Public Affairs Digest by Olivia P. Walker, MPA
Generic Drugs

FDA Competitive Generic Therapy Designation: Terms and Conditions

The accelerated implementation of CGT is part of the FDA’s plan to lower the amount of money Americans pay for medicine.

Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition. FDA Commissioner Gottlieb

The FDA wants to increase competition in the generic drug market. On top of that, the FDA wants to cut drug prices. Accordingly, the CGT approval pathway reduces the time it takes for generic drugs to reach the market. CGT lessens the required drug review cycles during drug review processes. The following provides  important information about the CGT designation. Note: bulleted text taken directly from today’s press release.

  • Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA).
  • Applicants for drugs that receive a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions.
  • Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 days after the date of approval of its ANDA or it will forfeit its exclusivity.
  • The agency requires ANDA applicants to demonstrate that all aspects of their drug product meet the FDA’s rigorous approval standards that ensure an equivalent, high quality, safe and effective generic medicine.
  • As with brand-name drugs, the FDA reviews manufacturing and packaging facilities for generic drugs to ensure they are capable of consistently producing quality products.

The FDA also approved a new cancer treatment today. 

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The FDA has proposed a series of new steps to modernize the functions of the Office of New Drugs.

Proposed Modernization of FDA’s Drug Review Office

The Food and Drug Administration (FDA) released a statement today on its plan to assure American’s have access to safe and effective drugs and biologics. The plan entails modernizing the functions of the Office of New Drugs to align organizational operations with advances in science and medicine. Moreover, the proposed modernization of FDA’s Drug Review Office is a strategy to ensure alignment between innovation and regulation.

The Food and Drug Administration released its plan to provide American's with access to safe and effective drugs and biologics. Click To Tweet

With this progress comes more complexity. Not only challenges related to the science of how drugs are discovered, but also the manner in which they’re developed. For very novel drugs targeting unmet needs, this often doesn’t follow the traditional three phases of clinical trials.

The Office of New Drugs

The Office of New Drugs is a division within the FDA’s Center for Drug Evaluation and Research (CDER).  To help the FDA meet its public health goals, the Office of New Drugs is responsible for:

  • Reviewing applications and deciding if drugs and biologics meet safety and efficacy standards;
  • Setting guidance and policy to ensure efficient drug review processes;
  • Overseeing investigational studies during drug development;
  • Determining marketing approvals for new innovator or non-generic drugs — and making decisions related to products already in the market;
  • Providing guidance to industry on clinical, scientific, and regulatory matters;
  • Overseeing the 21st Century Review Initiative;
  • Regulating over the counter drugs (OTC) and drug labeling; and
  • Maintaining and updating databases containing information about drug shortages, post-market studies, clinical trials, generic drugs, OTC drugs, and biological therapeutic products.

Click here for more on the Office of New Drugs.

Advances in science and medicine require the FDA to adapt its structure and processes.
Advances in science and medicine require the FDA to adapt accordingly.

Proposed Modernization of FDA’s Drug Review Office

The FDA’s proposed modernization efforts include structural changes and process revisions.

The FDA has introduced many fundamental advances in how it evaluates drugs for safety and effectiveness, as well as the manner in which clinical trials are guided. These include adaptive approaches to clinical development such as the introduction of seamless trial designs or master protocols or tissue agnostic product approvals.

The Plan

Dr. Janet Woodcock, Director of the CDER, has set goals and proposed new steps to modernize the organization and functions of CDER’s Office of New Drugs. The stated goals and proposed steps include:

  • Issuing more product-specific guidance documents. The plan is to develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect the latest science;
  • Implementing new organizational structures to allow review staff to have more time for reviewing and providing feedback to sponsors on clinical protocols;
  • Engaging sponsors earlier in the development process to ensure that trial designs are efficient and structured in the most effective way to identify risks and measure outcomes;
  • Expanding the Office’s ability to engage external stakeholders, such as disease specialists, academic researchers, external regulatory partners, and patient groups. Patient-focused drug development is becoming an industry trend;
  • Creating many new therapeutic-specific divisions that will have more ability to engage in discrete areas of medicine; and
  • Better organizing the entire review process and the development of the key review memos to enable  medical staff to efficiently document their findings. This will allow medical staff to spend more of their time on advancing scientific work in their fields and less time documenting and performing administrative tasks.

We believe the new alignment and processes will improve efficiency by 20 percent at a minimum overall […] We’ll engage the external community more closely in our work, especially patients who inform our patient-focused drug development, with the aim of advancing more modern regulatory principles.

Key Takeaways

Ultimately, the proposed modernization of the FDA’s Drug Review Office is an attempt to:

  • Ensure the organizational structure consistently follows the subdivisions of medicine;
  • Streamline processes to enhance operational efficiencies and communication flows;
  • Assure American’s have access to safe and effective drugs and biologics; and
  • Achieve alignment between innovation and regulation.

The FDA wants to achieve alignment between innovation and regulation. Click To Tweet

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