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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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solutions for pharmaceutical manufacturers who participate in the Medicaid Drug Rebate Program and pay too much because of 340b duplicate discounts

Drug Pricing: Tech Start-Up Provides Solutions for Drug Manufacturers Subject to 340B Duplicate Discounts

The extent to which 340B covered entities receive duplicate discounts from pharmaceutical manufacturers who take part in the Medicaid Drug Rebate Program (MDRP) is widely documented.

The Medicaid Exclusion File

The Health Resources and Services Administration (HRSA) established the 340B Medicaid Exclusion File (MEF) as The mechanism to aid 340B covered entities and states to prevent duplicate discounts for drugs subject to Medicaid rebates.

But in terms of efficacy, the MEF is insufficient in mitigating duplicate discounts. An estimated $2 billion in improper rebate payments are paid by pharmaceutical manufacturers — and received by 340B covered entities — on an annual basis. Continue reading “Drug Pricing: Tech Start-Up Provides Solutions for Drug Manufacturers Subject to 340B Duplicate Discounts”

115th Congress: Pharmaceutical Industry, Medicare, ACA, 340B – Legislation to Watch

Legislative measures aim to solve problems as defined by members of Congress. Once a bill passes both Chambers, the President will either sign the bill into law or veto it. If passed, the new law —  or act —  is codified in the United States Code (U.S.C).

REGULATIONS 

Once codified, federal agencies create rules and regulations — published in the Federal Register (FR) — to carry out the laws passed by Congress. Regulatory agencies act with broad discretionary authority and within limits set by Congress and the Constitution.

LEGISLATION TO WATCH

    1. S.2460 – Every Prescription Conveyed Securely Act – If passed in its current form, this bill will amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances.
    1. S.2453 – Ensuring the Value of the 340B Program Act of 2018 – If passed in its current form, this bill will amend title XVIII of the Social Security Act to require hospitals to provide the Secretary with information on the hospital’s acquisition costs for 340B drugs and the total revenues received by the hospital for such drugs.
    1. S.2476 – Expanding Access to Low Cost Generic Drugs Act – If passed in its current form, this bill will amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.
    1. S.2478 – End Taxpayer Subsidies for Drug Ads Act – If passed in its current form, this bill will amend the Internal Revenue Code of 1986 to deny the deduction for advertising and promotional expenses for prescription drugs.
  1. S.2554 – Patient Right to Know Drug Prices Act – If passed in its current form, this bill will amend Section 1311(e) of the Patient Protection and Affordable Care Act by adding at the end the following:

(4)  INFORMATION ON PRESCRIPTION DRUGS. —The Exchange shall require health plans seeking certification as qualified health plans to ensure that—  “(A) the health insurance issuer does not restrict any pharmacy that dispenses a prescription drug to an enrollee in the plan from informing (or penalize such pharmacy for informing) an enrollee of any differential between the price of the drug to the enrollee under the plan and the price the individual would pay for the drug if the enrollee obtained the drug without using any health insurance coverage; and

“(B) any entity that provides pharmacy benefits management services under a contract with any such health plan does not, with respect to such plan or any health benefits plan that the entity contracts with to provide pharmacy benefits management services and that is offered by an entity other than such sponsor or organization, restrict a pharmacy that dispenses a prescription drug from informing (or penalize such pharmacy for informing) an enrollee of any differential between the price of the drug to the enrollee under the plan and the price the individual would pay for the drug if the enrollee obtained the drug without using any health insurance coverage.”

(b) Other Health Plans. —The provisions of section 1311(e)(4) of the Patient Protection and Affordable Care Act (as added by subsection (a)) shall apply to all health insurance issuers with respect to health insurance coverage and to all group health plans (as such terms are defined in section 2791 of the Public Health Service Act).

Notably, (a) not all measures [necessarily] pass through the Chamber in which they are introduced — similarly,  not all measures that pass through one or both Chambers will [necessarily] pass in their current form and (b) it is important to consider the (Party) composition of Congress in relation to the political (Party) affiliation(s) of the President and a bill’s sponsor — and co-sponsor(s) when gauging the likelihood of a legislative measure becoming law [this should not be taken to mean that ALL legislative measures lack bipartisan support].

LEGISLATION BEGETS REGULATION

The pharmaceutical industry, the 340B program, health plans, hospitals, and Medicare Part D are highly regulated. Government action profoundly impacts industry’s operations, products and business development goals. Strategically, the value of proactively tracking legislation cannot — and should not — be underscored.

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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

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.

ACCELERATED APPROVAL

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.”

WHY THIS MATTERS 

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.

GUIDANCE FOR INDUSTRY 

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