Big Pharma Skepticism – What are we consuming?

Author

Pharm. Mustafa Abacıoğlu

International Sales Specialist – AMEX Healthcare Industrial Pharmacy Board Member – International Pharmaceutical Federation (FIP) International Relations Secretary – NCODA International Oncology Association

"Let’s talk about and how medications are approved and regulated."

Büyük İlaç Şüpheciliği – Ne tüketiyoruz?

Title: | How skeptical should we be about the medications we consume? | How do I know if the drugs I consume are safe? | What about generics, are they also safe? | To summarize

How skeptical should we be about the medications we consume?

Well as skeptical as possible of course! At the end of the day, medicine is the most important consumable we take into our bodies. As common sense, we all want to make sure that all products we purchase and consume are at the highest possible quality and lowest possible cost. When it comes to our healthcare, this is even more crucial as we want to make sure the pharmaceutical products we consume will fix our problem, won’t harm us, and won’t be manufactured poorly.

This is well defined and established as the two main pillars that regulatory authorities put into the decision-making of drugs: efficacy and safety (quality is sometimes also seen as a third pillar, but can also be considered under safety).

How do I know if the drugs I consume are safe?

To better understand this, let’s walk through how a drug goes from a research project in a lab to the blister we pop open in hopes of relieving a headache. The Department of Health and Human Services Food and Drug Administration (FDA) is a regulatory body that oversees the efficacy and safety of medications sold in the United States of America (US) and has an impact on a lot of regulatory authorities around the world when it comes to their decision making for drug approvals. The FDA splits up its duty into two stages: they analyze applications from manufacturers to market pharmaceuticals in the US during the preapproval (premarket) phase; a drug cannot be sold in the US unless it obtains FDA approval. The FDA keeps an eye on a drug's efficacy and safety after it is put on the market. The duration of the post-approval phase is equal to the duration of the drug's sale.

The process of getting a medicine approved begins well before the FDA is involved. First, fundamental scientists conduct research on animals in labs; next, a biotechnology or pharmaceutical company creates a prototype medication. To evaluate the product on human subjects, that company must apply for and acquire FDA permission through an investigational new drug (IND) application. It conducts those experiments, known as clinical trials, in Phase I, II, and III investigations, which progressively increase the number of participants. The data and analysis obtained are then assembled by the manufacturer into a new drug application (NDA).

The FDA then evaluates the NDA with a focus on three main issues: (1) the drug's safety and efficacy in the intended use; (2) the suitability of the proposed labeling; and (3) the suitability of the manufacturing processes to ensure the drug's identity, strength, quality, and purity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and its implementing regulations specify every stage's requirements. When a treatment may be able to treat a serious illness or condition, an unmet need, or both, the FDA uses a few unique procedures to speed up the review and development of that drug.

The FDA continues to monitor drug manufacture, distribution, and use even after an NDA is authorized, allowing the drug to be sold in the United States. Governments have historically been interested in several topics related to drug safety and effectiveness, including product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and direct-to-consumer advertising.

The FDA works to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired medications through technology, inspections, chain-of-custody documentation, and product and facility registration. When an NDA is approved by the FDA, the medicine's labeling is also approved; but, once a drug is on the market, the FDA may demand revisions based on new information. It also forbids manufacturers from promoting uses for their products that are not included on the label. Manufacturers are required by the FFDCA to report to the FDA any adverse occurrences relating to their products; physicians and other members of the public are also able to report adverse events to the FDA. After initially concentrating on assessments of different adverse-event databases, the agency's surveillance of drug-related issues is now extending to more active applications of developing computer technology and ties to other data.

The FDA may mandate that a manufacturer carry out post-approval studies for pharmaceuticals under the FFDCA. The statute outlines when the FDA may issue the requirement following a drug's release onto the market and when it must be attached to the NDA approval. The FDA may also demand patient or physician guidelines and distribution limits in order to handle unusual medication hazards. The agency controls the industry's advertising of its goods to physicians and the general public, as well as the public's access to information regarding the safety and efficacy of drugs.

What about generics, are they also safe?

The U.S. Food and Drug Administration (FDA) places a high focus on working to ensure a supply of generic medications that are affordable, safe, and made in accordance with its strict quality requirements in order to give patients access to the medications they need. 90% of prescriptions filled in the US today are FDA-approved generic medications, and over the past ten years, generic competition has saved the healthcare system around $1.67 trillion. The FDA reviews new applications for generic drugs to make sure the drugs work in the same way in the body, contain the same active components, and may be used under the same circumstances as their name-brand equivalents. Generic medications are just as safe and effective as name-brand medications and are subject to strict regulatory requirements.

More than 1,000 generic medications were approved or provisionally approved in 2018, which is roughly equal to the amount approved in 2017. More new generic medications on the market lowers costs while simultaneously improving access, a crucial safety component. For example, when a shortage occurs due to a problem with one or more of these manufacturers, the market availability of a generic drug made by only one or very few manufacturers can have a direct influence on public health. Natural disasters and other unanticipated events have taught us that diversifying manufacturing facilities is essential to long-term safety.

To summarize

As we had initially set the stage, it is the most natural thing for us to be skeptical when we put something in our body, especially when that thing needs to treat a disease or relieve pain. On the other hand, knowing that there are institutions that approve and monitor drugs very stringently should give us more peace of mind and a resource to know exactly how drugs are being evaluated. At the end of the day, regulations can only be as strong as our current scientific knowledge which is constantly evolving. Therefore, we need to keep this in mind and know that these authorities are constantly working to update themselves and stay relevant.

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https://pubmed.ncbi.nlm.nih.gov/31935033/

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https://pubmed.ncbi.nlm.nih.gov/36496207/

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6. Janet Woodcock, M.D. Safety, Efficacy, and Quality Remain Top Priorities as We Continue Our Work to Expand Access to Cost-Saving Generic Drugs for the American Public (2019).