What was the FDA’s final decision on Mepergan Fortis Capsules. How did the administrative law judge rule on the drug’s effectiveness. Why did the FDA deem the application exceptions withdrawn.

Background on Mepergan Fortis and FDA Drug Review Process

Mepergan Fortis Capsules (MFC) is a combination drug containing meperidine HCl and promethazine HCl. The drug was originally developed for use as a sedative and analgesic for patients experiencing moderate pain and apprehension, such as those recovering from surgery or trauma. However, its path to FDA approval has been long and complex.

In 1962, amendments to the Federal Food, Drug, and Cosmetic Act required that all new drugs demonstrate both safety and efficacy before approval. This led the FDA to review drugs approved between 1938-1962 through the Drug Efficacy Study Implementation (DESI) program. As part of this process, in 1972 the FDA classified MFC as “possibly effective” for moderate to moderately severe pain, but stated that additional evidence was needed to establish its effectiveness.

The Supplemental New Drug Application for Mepergan Fortis

Following the FDA’s 1972 classification, Wyeth (a division of American Home Products) submitted a supplemental new drug application (sNDA) for Mepergan Fortis Capsules. This sNDA was a supplement to the previously approved NDA for Mepergan Injection.

In 1981, the FDA proposed to refuse approval of the sNDA for MFC. Wyeth requested a hearing on this decision, which was granted in 1984. The hearing, conducted by an Administrative Law Judge (ALJ), took place in January 1986.

Key Findings of the Administrative Law Judge

After reviewing the evidence presented at the hearing, ALJ Daniel J. Davidson issued his Initial Decision on December 4, 1987. The ALJ’s ruling contained three key findings:

1. The effectiveness of Mepergan Fortis Capsules had not been proven by substantial evidence from adequate and well-controlled clinical trials.
2. The requirements of the FDA’s combination drug policy had not been met.
3. Mepergan Fortis qualified as a “new drug” under 21 U.S.C. 321(p).

These findings effectively supported the FDA’s proposal to refuse approval of the sNDA for Mepergan Fortis Capsules.

The Appeals Process and Final FDA Decision

Following the ALJ’s Initial Decision, Wyeth filed exceptions to appeal the ruling. However, recent developments have led to a conclusion of this long-standing case.

The FDA recently reached out to the current owner of the sNDA application, requesting confirmation of their desire to continue pursuing the appeal. When the applicant failed to affirm their intent within the specified timeframe, the FDA deemed the exceptions as withdrawn.

As a result of this withdrawal, the case reverted to the same procedural position it would have been in if no exceptions had been filed against the ALJ’s Initial Decision. Consequently, the ALJ’s Initial Decision has become the final decision of the FDA Commissioner by operation of law.

Implications of the FDA’s Final Decision on Mepergan Fortis

The FDA’s final decision to refuse approval of the sNDA for Mepergan Fortis Capsules has significant implications for the drug and its potential use in medical practice. Can Mepergan Fortis still be prescribed or marketed? No, as a result of this decision, Mepergan Fortis Capsules cannot be legally marketed or prescribed in the United States. The drug has not met the FDA’s standards for safety and efficacy, and it has not satisfied the requirements for combination drug products.

Impact on Pain Management Options

The rejection of Mepergan Fortis may impact the range of treatment options available for patients with moderate pain and apprehension. Healthcare providers will need to rely on other approved medications or combinations to address these symptoms in post-operative and post-trauma patients.

Lessons for Pharmaceutical Companies

This case highlights the importance of conducting robust clinical trials and meeting all regulatory requirements when seeking FDA approval for new drugs or new formulations of existing drugs. It also underscores the potential consequences of failing to actively pursue appeals in the regulatory process.

Understanding the FDA’s Combination Drug Policy

One of the key reasons for the rejection of Mepergan Fortis was its failure to meet the FDA’s combination drug policy. What is the FDA’s combination drug policy? The FDA’s combination drug policy requires that each component of a combination drug contributes to the claimed effects and that the dosage of each component is such that the combination is safe and effective for a significant patient population.

For Mepergan Fortis, which combines meperidine (an opioid analgesic) with promethazine (an antihistamine with sedative properties), the manufacturer would have needed to demonstrate that:

• Both components contribute to the claimed effects of sedation and analgesia
• The specific doses of each drug in the combination are appropriate
• The combination is safe and effective for a significant group of patients
• The combination provides a benefit over individual administration of the components

The ALJ’s decision indicates that Wyeth failed to provide sufficient evidence to satisfy these requirements for Mepergan Fortis.

The Significance of “New Drug” Classification

Another important aspect of the ALJ’s decision was the classification of Mepergan Fortis as a “new drug” under 21 U.S.C. 321(p). Why is this classification important? The “new drug” designation has significant regulatory implications:

1. It requires the manufacturer to submit a full New Drug Application (NDA) with comprehensive data on safety and efficacy.
2. The drug cannot be marketed without FDA approval of the NDA.
3. It subjects the drug to more stringent post-marketing surveillance and reporting requirements.

This classification effectively means that Mepergan Fortis would need to go through the full FDA approval process, including extensive clinical trials, before it could be marketed in the United States.

The Role of Substantial Evidence in FDA Drug Approvals

A critical factor in the rejection of Mepergan Fortis was the lack of substantial evidence demonstrating its effectiveness. How does the FDA define substantial evidence? According to the FDA, substantial evidence consists of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience, that provide a reasonable basis to conclude that the drug will have its intended effect.

For Mepergan Fortis, this would have required:

• Multiple well-designed clinical trials
• Clear demonstration of efficacy for the claimed indications
• Robust statistical analysis of trial results
• Evidence of safety in the target patient population

The ALJ’s decision indicates that the evidence provided by Wyeth fell short of these standards, highlighting the high bar set by the FDA for drug approvals.

The Importance of Adequate and Well-Controlled Studies

The FDA places great emphasis on the quality and design of clinical studies used to support drug approvals. What constitutes an adequate and well-controlled study? Key elements include:

• Clear objectives and analysis plans established before the study begins
• Use of a control group (placebo, active treatment, or historical control)
• Randomization of subjects to minimize bias
• Measures to minimize subject and investigator bias (e.g., blinding)
• Well-defined and reliable methods of assessing subject response
• Analysis of results that is adequate to assess the effects of the drug

The absence of such rigorous studies for Mepergan Fortis likely contributed significantly to its failure to gain FDA approval.

Lessons from the Mepergan Fortis Case for Drug Development

The lengthy and ultimately unsuccessful journey of Mepergan Fortis through the FDA approval process offers several important lessons for pharmaceutical companies and drug developers:

1. The Critical Nature of Clinical Trial Design

The case underscores the paramount importance of designing and conducting clinical trials that meet the FDA’s standards for adequate and well-controlled studies. Companies must invest in robust trial designs that can clearly demonstrate both the safety and efficacy of their products.

2. Challenges of Combination Drug Products

Developing combination drugs presents unique challenges. Manufacturers must be prepared to provide evidence that each component contributes to the claimed effects and that the combination offers advantages over individual administration of the components.

3. The Ongoing Nature of Drug Regulation

The Mepergan Fortis case, which spans several decades, illustrates how drug regulation is an ongoing process. Changes in regulatory requirements, such as the 1962 amendments requiring proof of efficacy, can have long-lasting impacts on drug approvals.

4. The Importance of Actively Pursuing Regulatory Processes

The final decision in this case came about partly because the current owner of the sNDA failed to affirm their desire to continue the appeal. This highlights the need for companies to actively engage with regulatory processes and respond promptly to FDA communications.

5. The Value of Historical Context in Drug Development

Understanding the regulatory history of similar products or previous attempts to gain approval can provide valuable insights for current drug development efforts. The challenges faced by Mepergan Fortis could inform strategies for developing and seeking approval for new pain management combinations.

By learning from cases like Mepergan Fortis, pharmaceutical companies can better navigate the complex landscape of drug development and FDA approval, potentially improving their chances of bringing safe and effective new treatments to patients.

Mepergan Fortis Capsules; Final Decision on Proposal To Refuse Approval of Supplemental New Drug Application; Availability of Final Decision

Start Preamble

Food and Drug Administration; HHS.

Notice.

The Food and Drug Administration (FDA or the Agency) is announcing that the Initial Decision of the Administrative Law Judge (ALJ), to refuse approval of the supplemental new drug application (sNDA) for Mepergan Fortis Capsules (MFC) (meperidine HCl, promethazine HCl), is the final decision of the Commissioner by operation of law. In the Initial Decision, the ALJ found that MFC had not been shown to be supported by substantial evidence consisting of adequate and well-controlled studies to be effective for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms; that the drug did not satisfy the combination drug policy; and that it is a “new drug. ” The sNDA applicant filed exceptions to the ALJ’s Initial Decision. FDA recently requested that the current owner of the sNDA application affirm its desire to pursue the appeal of the ALJ’s Initial Decision; however, the applicant did not affirm its desire to pursue the appeal within the specified timeframe. Accordingly, FDA now deems those exceptions as withdrawn. Consequently, the proceeding is in the same procedural position as if no exceptions to the ALJ’s Initial Decision had been filed; therefore, the ALJ’s Initial Decision has become the final decision of the Commissioner by operation of law.

This final decision is effective November 16, 2017.

For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 between 9 a. m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket.

Start Further Info

Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.

End Further Info
End Preamble
Start Supplemental Information

I. Background

In 1962, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) was amended by the Drug Amendments Act of 1962, and these amendments provided that new drugs could no longer be approved unless both safety and efficacy had been established for them. As amended, the FD&C Act also required FDA to evaluate drugs approved as safe between 1938 and 1962 to determine whether such drugs were effective and to withdraw approval for any new drug application (NDA) where there was not substantial evidence of the drug’s effectiveness. The person contesting the withdrawal of the approval had the burden of coming forward with evidence of effectiveness for the drug. FDA’s review of these pre-1962 drugs is known as the Drug Efficacy Study Implementation (DESI) program.

In a document published in the Federal Register of April 20, 1972 (37 FR 7827), after evaluating reports received from the National Academy of Sciences/National Research Council, Drug Efficacy Study Group, and other available evidence, FDA classified MFC as “possibly effective” for moderate to moderately severe pain. This document also stated that no NDA had been approved or deemed approved for MFC and that additional evidence needed to be submitted to FDA to establish MFC’s effectiveness. Thereafter, Wyeth, a division of American Home Products (Wyeth), submitted a supplement to its approved NDA 11-730 (Mepergan Injection) for MFC (NDA 11-730, S-003). In a document published in the Federal Register of September 18, 1981 (46 FR 46404), the Director of the Bureau of Drugs (now the Center for Drug Evaluation and Research) proposed to refuse approval of the sNDA and offered Wyeth the opportunity for a hearing.

Wyeth submitted its request for a hearing and, by a document published in the Federal Register of December 31, 1984 (49 FR 50788), the Office of the Commissioner granted the hearing request. Following the submission of written testimony and documentary evidence, an ALJ, Daniel J. Davidson, conducted a hearing from January 14 to 17, 1986. He issued his Initial Decision on December 4, 1987. The ALJ found that: (1) The effectiveness of MFC had not been proven by substantial evidence of adequate and well-controlled clinical trials, (2) the requirements of the combination drug policy had not been met, and (3) MFC is a new drug under 21 U.S.C. 321(p). Wyeth timely appealed the ALJ’s Initial Decision by filing exceptions with the Commissioner under 21 CFR 12.125.

On August 23, 2017, FDA sent a letter to West-Ward Pharmaceuticals Corporation (West-Ward), successor to Wyeth, to determine whether West-Ward remained interested in pursuing its appeal of the ALJ’s Initial Decision. FDA informed the company that if it did not respond and affirm its desire to pursue its appeal by September 21, 2017, the Office of the Commissioner would conclude that West-Ward no longer wishes to pursue the appeal of the ALJ’s Initial Decision and will proceed as if the appeal has been withdrawn. The Office of the Commissioner did not receive a response from West-Ward by the given date; therefore, the Commissioner now deems the exceptions withdrawn.

II. Conclusion and Order

Given that the exceptions have been deemed withdrawn, this proceeding is now in the same procedural posture as if no exceptions had ever been filed. When parties do not file exceptions to the ALJ’s Initial Decision, and the Commissioner does not file a notice of review, the ALJ’s Initial Decision becomes the final decision of the Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice in the Federal Register when an initial decision becomes the final decision of the Commissioner without appeal to or review by the Commissioner (see 21 CFR 12. 120(f)).

Therefore, the ALJ’s Initial Decision is the final decision of the Commissioner effective November 16, 2017. Pursuant to the findings in the ALJ’s Initial Decision, under section 505(d) of the FD&C Act (21 U.S.C. 355(d)) and under the authority delegated by the Secretary of Health and Human Services, the Commissioner finds that there is a lack of substantial evidence that MFC will have the effect it purports or is represented to have under the conditions of use prescribed, Start Printed Page 53508recommended, or suggested in its labeling for sedation and analgesia in patients with concurrent moderate pain and apprehension, such as postoperative and post-trauma patients with those symptoms. The Commissioner further finds that MFC does not meet the combination drug policy in 21 CFR 300.50 and that it is a “new drug” within the meaning of 21 U.S.C. 321(p). Therefore, approval of the sNDA for MFC is denied. Distribution of products subject to the ALJ’s Initial Decision in interstate commerce without an approved application is prohibited and subject to regulatory action (see, e. g., sections 505(a) and 301(d) (21 U.S.C. 331(d)) of the FD&C Act).

The full text of the ALJ’s Initial Decision may be seen in the Dockets Management Staff and in this docket (see ADDRESSES).

Start Signature

End Signature
End Supplemental Information

[FR Doc. 2017-24806 Filed 11-15-17; 8:45 am]

BILLING CODE 4164-01-P

Memorable misfills of a retail pharmacist

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000″>Apr 16, 2007

Every pharmacist has his own horror stories that are seared into his brain. Here are some that stand out in my mind.

1. Mepergan Fortis/cephalexin: A pharmacist told me this story. She discovered that she had dispensed Mepergan Fortis (meperidine/promethazine, Wyeth) (a powerful narcotic pain reliever) instead of cephalexin 500 mg (an antibiotic). It’s easy to see how this error occurred. Both are dark red capsules. She called her husband and told him to go to the customer’s house to retrieve the Mepergan Fortis. She cried into the phone to her husband: “GO GET IT! GO GET IT!” Her voice broke as she told me the story.

5. Carbamazepine/theophylline: A local doctor told me that one of his patients was in his office “and he’s dying.” The doctor proceeded to tell me that we had dispensed carbamazepine (which treats seizures) rather than theophylline (which treats asthma). We had dispensed the drugs in the manufacturer’s original container, so the doctor knew the contents from the exposed label. After I listened to the doctor’s tirade, I asked, “Are you serious that he’s dying?” The doctor said, “No, but he’s pretty damned mad. His asthma has been out of control for a week.” I finally asked the doctor the question that was uppermost on my mind: “Which pharmacist’s name is on the bottle?” It turned out to be my partner’s name. I told the doctor that I was not responsible for the error, so he backed off. I found out later that my partner was indeed sued.

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Fortis – equipment for rehabilitation

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FORTIS | Participant of the Skolkovo project

LIMITED LIABILITY COMPANY “FORTIS”

Primary activity (OKVED)

62.01 –

Development of computer software

About the company

The company “Fortis” (part of the MONOPOLY Group) develops scalable logistics services for the market of moving goods by road. The main product of the company is the high-tech web platform Monopoly.online, which hosts services for solving transport logistics problems. The company strives to solve the problem of digital disruption of the logistics industry, build a real holistic ecosystem for transport companies, retailers and manufacturers of goods, implement a full-fledged sharing economy and aggregation of resources participating in the industry. To solve these problems, the company has united in one place the best IT specialists of the country with relevant competencies and extensive experience in building an effective transport business for the MONOPOLY company. The company employs 167 employees. General Director: Mikhailova Ekaterina Vladimirovna. Founders: Monopoly JSC (

The company operates in the regions

St. Petersburg

Company maturity assessment

6

CRL (company readiness level)

8

IRL (investment readiness level)

Main activity (OKVED)

62.01 –

Computer software development

Projects

Business model

Business to Business to Consumer (B2B2C) Business to Business (B2B)

Project maturity assessment

9

TRL (Technology readiness level)

9

MRL (Market readiness level)

9 0002 Description of the project

ensuring the process of cargo transportation.
The solution is a digital platform that combines all the services necessary for organizing cargo transportation, from cargo search to cardless fuel processing and services from a network of proven road complexes throughout Russia.
The main functionality has been implemented: searching for cargo, paying for fuel and services of road complexes, receiving payments for transportation.
The immediate goals are to close the entire customer path of the cargo carrier into an ecosystem of products.

Products

Product Description

Multiservice
MONOPOLY.MULTISERVICE
MONOPOLY.Multiservice
Monocard

Register of Russian programs for electronic computers and databases

https://reestr.digital.gov.ru/reestr/1445121/

URL of the copyright holder’s website with information

https://multiservice99.monopoly.su /

Product type

Software

Product description

The digital logistics platform monopoly.online combines the services necessary for the organization of cargo transportation: search for cargo and carriers, payment for fuel and roadside services. The platform is designed for the efficient organization of cargo transportation, at the moment the platform provides the possibility of agreeing on an application for the transportation of goods, creating a convenient route for cargo transportation, searching for cargo taking into account the needs of the cargo carrier, and more.

Product maturity assessment

8

TRL (Technology readiness level)

9

MRL (Market readiness level)

Project team

262 people

Revenue

368 112 000 ₽

Volume of attracted investments

425 800 000 ₽

Rates growth

901 82

Contact now

Analytics

0002 Financial indicators

Balance sheet

Taxes

Headcount

Intellectual property

Company Information

Founders

JOINT STOCK COMPANY “MONOPOLIA”

100%

MONOPOLY

0%

Share capital

10,000 ₽

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