Regulating Beauty

Updated July 31

Regulating Beauty

Regulating Beauty|Mainstream media, Hollywood and the beauty industry define beauty standards. Meaning, society regulates beauty by defining it. And government regulates the beauty industry. Regulating Beauty is a stylish, relevant and educational series,  starting  August 2019.

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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
Olivia P. Walker in Silicon Valley attending an event focused on technology and innovation
Photo of Olivia Walker, author and editor of all content published on O.W.B Public Affairs Digest
Regulatory Health. Medicaid. Public Health. Health Policy. Pharma. Biopharma.

FDA’s Recent Approval of Radioactive Drug Reveals Criteria for Market Entry

On 26 January, the U.S. Food and Drug Administration (FDA) announced its approval of the first radiopharmaceutical — a drug that contains a radioactive substance — for the treatment of GEP-NETS, a rare group of digestive tract cancers.

According to an  FDA News Release, “This approval demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment.” The name of the drug is Lutathera. Lutathera was approved through an accelerated approval application process.


Expanded Access programs are regulatory mechanisms by which patients are granted access to investigational drugs — to include biologics and medical devices. Investigational drugs are not FDA approved. Meaning, their safety and efficacy have yet to be determined via clinical trials. Notwithstanding, the aforementioned provide treatment options to individuals suffering from detrimental cancer diagnoses with unmet medical needs.


Section 901 of the Food and Drug Administration Safety Innovations Act (FDASIA) enabled the FDA to approve Lutathera under an accelerated approval application. When Congress passed the FDASIA in 2012, the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended to allow the FDA to approve certain drugs provided a “drug has an effect on a surrogate or an intermediate clinical endpoint […] The FDA bases its decision on whether to accept the proposed surrogate or intermediate clinical endpoint on the scientific support for that endpoint. Studies that demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint must be ‘adequate and well controlled’ as required by the FD&C Act.”


For Patients – One out of 27,000 people are diagnosed with GEP-NETs per year. The FDA’s approval of Lutathera expands patient access to quality health care by providing treatment in the absence of clinically tested drugs.

For Pharmaceutical Manufacturers & Industry Stakeholders – The approval of Lutathera reveals the criteria for market entry. The following two paragraphs entail language extracted directly from the FDA’s press release:

  • The approval of Lutathera was supported by two studies. The first was a randomized clinical trial in 229 patients with a certain type of advanced somatostatin receptor-positive GEP-NET. Patients in the trial either received Lutathera in combination with the drug octreotide or octreotide alone. The study measured the length of time the tumors did not grow after treatment (progression-free survival). Progression-free survival was longer for patients taking Lutathera with octreotide compared to patients who received octreotide alone. This means the risk of tumor growth or patient death was lower for patients who received Lutathera with octreotide compared to that of patients who received only octreotide.
  • The second study was based on data from 1,214 patients with somatostatin receptor-positive tumors, including GEP-NETS, who received Lutathera at a single site in the Netherlands. Complete or partial tumor shrinkage was reported in 16 percent of a subset of 360 patients with GEP-NETs who were evaluated for response by the FDA. Patients initially enrolled in the study received Lutathera as part of an expanded access program.


Click here for FDA—Expanded Access to Investigational Drugs—guidance updated October 2017.