FDA Drug safety analysis and approval process

FDA drug approval process

The U.S. Food and Drug Administration on 25th April 2017 has issued warning letters addressed to 14 U.S.based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The FDA in his press release has mentioned that these products are marketed and sold without FDA approval, most commonly on websites and social media platforms. The FDA has initiated enforcement actions against companies that illegally market products that claim to prevent, diagnose, treat, mitigate or cure cancer. In addition to warning letters, several firms have been subject to permanent injunctions and criminal prosecutions.

FDA on cancer drugs

The products blacklisted include a variety of product types such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices) which are marketed for use by humans or pets. The products were sold with unproven claims of preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Check out the list of 65 drugs and it’s manufacturing companies which are blacklisted by FDA.

Why are some drugs which are not showing any side effects are been banned by FDA?

There are various reasons behind FDA’s decision on issuing a warning letter or banning the drug and blacklisting the drug and drug companies. Some of the main factors behind those decisions are:

  • The banned drug has not been tested in a clinical trial experiment to show that the drug is safe for human use with no side effects.
  • When a medication’s risks and known dangers outweigh its benefits, FDA and/or the manufacturer may decide that the product should be withdrawn from the market.
  • Few drugs are released into the market when they are still in a clinical trial phase of drug discovery.
  • Some drugs have been proven safe for a small population of human volunteers during the clinical trial phases but have shown severe side effects on post-marketing release to a large population.
  • Drugs are withdrawn from the market after finding its contamination during the primary investigation by FDA.
  • Don’t have sufficient data from drug manufacturer to prove that it is safe for use in the specific region of the country and for specific age groups for which they are marketing.

What are the steps followed by companies during Drug discovery and its approval?

Drug discovery and development in the Preclinical stage:

The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application (IND) for FDA’s review prior to testing in humans.

Clinical research Stage:

The company performs a series of clinical trials in humans in three phases, which FDA monitors, to test if the drug is effective and safe. Know more about the Clinical research basics.

FDA review and approval (Pre-marketing release):

Once the company has finished its clinical trial and found the positive results, the company sends its data from all the tests to FDA’s Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.

If this review establishes that a drug’s benefits outweigh its known risks for its proposed use, the drug is approved for sale.

Postmarketing Drug safety analysis:

After the drug is on the market, the FDA monitors its performance in a number of ways. One of those ways is the through MedWatch, the agency’s safety information and adverse event reporting program, which receives reports of suspected adverse reactions (side effects of medicines) from consumers, health care practitioners and pharmaceutical companies. The FDA agency uses data from MedWatch databases about the information on prescription drug use and health outcomes to identify and understand side effects of medicines.

If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals. A statement is added to the drug label about the new safety concern to ensure continued safe and effective use of the drug. Occasionally, approved drugs may be withdrawn from the market for serious safety risks if it is determined that the overall risks outweigh any benefits the drug may provide.

What is MedWatch and its role in Drug safety analysis?

MedWatch is the FDA Safety Information and Adverse Event Reporting Program to report adverse events that public observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:

  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers.
  • Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products).
  • Medical devices (including in vitro diagnostic products).
  • Combination products.
  • Special nutritional products (infant formulas, and medical foods).
  • Foods/beverages (including reports of serious allergic reactions).

You can also check more for Voluntary Reporting for Consumers and Healthcare Professionals.

What are Over-the-Counter (OTC) medicines and how are they approved?

Over-the-Counter (OTC) medicines

Over-the-Counter (OTC) medicines are drugs that have been found to be safe and appropriate for use without the supervision of a health care professional such as a physician, and they can be purchased by consumers without a prescription. These are the drugs which are found in home medical kits to cure minor problems. Some of the First-aid medicines are considered as OTC drugs.

OTC drugs are sometimes approved under applications like new prescription drugs, but more often they are legally marketed without an application by following a regulation called an OTC drug monograph which tells the kind of ingredients may be used to treat certain diseases or conditions without a prescription, and the appropriate dose and instructions for use. OTC products that meet a monograph’s requirements may be marketed without FDA review.

OTC products that do not fit under an existing monograph must be approved under an application like the applications for prescription products.

Important tips for using over-the-counter medicines:

  • Always follow the printed directions and warnings. Talk to your health care provider before starting a new medicine.
  • Some peoples are allergic to some products used in medicine so know your body and its reaction to the medicine you are taking.
  • Stop using single medicine for all the disease, doing so will result in some long term side effects.
  • Intake of OTC medicines for a very long duration to treat minor problems like a headache, joint pains, common cold, cough etc may cause addiction of body to the medicine leading to the weakening of body’s immune system.
  • Medicines affect children and older adults differently due to the weak immune system so special care should be taken when taking over-the-counter medicines.
  • Women who are pregnant or breastfeeding should talk to their provider before taking any new medicine.
  • All medicines become less effective over time and should be replaced. Check the expiration date before using any product.
  • Don’t get attracted to promotional products while buying from the market as most of the products are with near expiry date or of old stock with the company has replaced the old medicine with new medicine.

What is the FDA’s regulation of drugs related ads?

FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) monitor all the drug companies’ promotional messages for fair balance and truthfulness. FDA is very strict on drug company misleading advertisements like:

  • A prescription drug that tells the drug’s benefits but not its risks.
  • A sales representative tells a doctor a prescription drug is effective for a use not in the FDA-approved product labeling.
  • A sales representative says, “Drug X delivers results in as little as 3 days,” but does not mention that clinical trials showed most results took 12 weeks, with only a few in 3 days.

What is the Direct-to-Consumer (DTC) drug advertising?

Provided by drug companies, these ads are advertising for prescription drugs which are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio and published in magazines and newspapers. They also appear online on various Social Medias.

Types of DTC Ads:

DTC advertisements are communicated on various modes like:

  • Various short promotional videos and audios about the prescription medicine which are broadcasted in TV, radios and in certain apps.
  • Product review article in newspaper, magazines and in social media platforms like LinkedIn, Facebook, Twitter etc.
  • Special product review interviews of healthcare professionals in TV and radio shows.

DTC advertisements come in three form:

  • Product claim ads: These name a drug and the condition it treats, and talk about both its benefits and risks.
  • Reminder ads: They give the drug’s name, but not the drug’s uses.
  • Help-seeking ads: These describe a disease or condition, but don’t recommend or suggest specific drugs.

Which are the countries allowing advertising of Direct-to-Consumer (DTC) drug?

Most of the countries allowed only advertising of over-the-counter (OTC) medicines which are not used for some of the common health problems like the common cold, cough, pain, sore throat etc. To date, only United States, New Zealand and Brazil permits DTC in the pharmaceutical industry.

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