My Autobiography: David Balleza K(C)atague: Have You Heard of Environmental Assessments for New Drugs and Biologics?

Wednesday, January 18, 2023

Have You Heard of Environmental Assessments for New Drugs and Biologics?

The latest Climate Change Calamities that has ravaged the State of California starting 3 weeks ago reminded me of an article I wrote about Environmental Assessments. Today may be the end of this atmospheric river this year, but I am sure this will happen again in the future. Here's the article for your information.

I believe most of my readers in this blog have not heard of environmental assessments requirement for new drugs and biologics applications submitted to the FDA. At that time, part of my job as a Review Chemist is to evaluate the adequacy of the Environmental Assessment (EA) report submitted by an applicant for new drug application. An EA is a concise public document that evaluates the potential risk for the drug or feed additive to cause significant environmental impacts. Using fate, exposure, and effects data, the EA focuses on relevant environmental issues relating to the use and disposal of drugs or feed additives (21 CFR 25.40).

Here's a summary of the guidance published for the information of the public and the pharmaceutical industry, published July, 1998. I hope you are curious enough that you will read it.

GUIDANCE FOR INDUSTRY Environmental Assessment of Human Drug and Biologics Applications

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses.

The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process.

FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.

Under the President's reinventing government (REGO) initiatives, announced in April 1995, FDA reevaluated and revised its environmental regulations to reduce the number of EAs required to be submitted by industry and, consequently, the number of findings of no significant impact(FONSIs) prepared by the Agency under NEPA. FDA issued for public comment a notice of proposed rule making on April 3, 1996 (61 FR 14922) (republished May 1, 1996 (61 FR 19476)),that proposed additional categorical exclusions for those actions that have been identified as normally not having a significant effect, individually or cumulatively, on the quality of the human environment.

The final rule was published on July 29, 1997 (62 FR 40569), and became effective August 28, 1997. All applications or petitions requesting Agency action (e.g., NDAs, abbreviated new drug applications (ANDAs),INDs, biologics license applications (BLAs), supplements to such applications) must be accompanied by either an EA or a claim of categorical exclusion.Failure to provide (1) a claim of categorical exclusion or (2) an adequate EA, is sufficient grounds for refusing to file or approve the application (21 CFR 314.101(d)(4), 601.2(a) and (c), and 25.15(a)). An EA that is adequate for filing is one that addresses the relevant environmental issues.

An EA adequate for approval is one that contains sufficient information to enable the Agency to determine whether the proposed action may affect significantly the quality of the human environment. This guidance provides information on when an EA should be submitted; it also makes recommendations on how to prepare EAs for submission of drug or biologics applications to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

This guidance has been prepared under the direction of the Chemistry Manufacturing Controls Coordinating Committee, Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. This guidance represents the Agency's current thinking on environmental assessments. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

For Details read:

https://www.fda.gov/media/70809/download

Meanwhile enjoy this photo from my collection:

No comments:

Highlights of My Professional Career

In my more than 40 years of professional career, I have experienced both working rank and file, as well as supervising the work of subordinates. I have worked in four private firms and the Federal Government, the Food and Drug Administration (FDA), where I retired. I enjoyed the challenges and difficulties of both types of job situations. This is the highlights of my work experience story.

My first job after completing my doctorate degree was a Chemist for Chemagro Corporation in Kansas City, Missouri. It was a subsidiary of Bayer Corporation, a German conglomerate. I worked for the analytical chemistry department comprised of about fifty people; half that number was either chemists or biologists. My specific task was to develop analytical methods for the detection of pesticide residues in plant and animal tissues. I worked on my own, similar to six other bench chemists, and we all reported to the same supervisor.

The firm sponsored my visa conversion from a student to a permanent resident, and I was able to legally work and reside in the United States with my family. The company generously took care of its employees. At the end of each successful year, everyone received a 13th month salary bonus. The employees and their families celebrated wonderful annual Christmas parties in a downtown Kansas City hotel, with dancing and free drinks for the whole night.

Inasmuch as I enjoyed and loved working for Chemagro for five years, I found a new job which offered a substantially higher pay. Due to my exemplary work performance, my supervisor preferred and lobbied for me to stay with the company. I had to turn him down because they could not match the package presented by my new employer. It was also a chance for me and my family to move and live in the US west coast, where the mild winter climate is bearable compared to the Midwest.

My next job was at the agricultural research division of Shell Development Company in Modesto, California. I was a Research Chemist, and again I worked individually, same as five other chemists who all reported to a supervisor. My specific duty was similar to my previous job. I worked for them for five years, until the company decided to get out of the pesticide business. They closed their research facility affecting the jobs of more than 200 employees.

My third industrial job was with the agricultural research division of Stauffer chemical company, located in Richmond, California. I was a Senior Research Chemist doing the same project as my two previous jobs. I worked for twelve continuous years for the company, with outstanding annual job performance. I became a Principal Research Chemist, the highest attainable non-supervisory position.

One day in 1986, my supervisor informed me that my job had been eliminated, and I had one day to vacate the facility. It was the most dreadful lay off experience in my life. I felt anger, sadness and humiliation to be dismissed from work with one day notice, after all the years of hard work invested for the company. This was an unforgettable incident and was the gloomiest point in my professional career.
The company terminated sixty research employees, who were upset of the bad news.

One of the chemists was distressed and expressed his outrageous anger by threatening the company and its workers. He told his supervisor of his intention to bomb and burn down the laboratory. He was immediately escorted by the security staff out of the building and into his car. He was informed to leave behind his personal belongings; they will be mailed to his residence. He was warned never to show up again near the company premises or risk getting arrested.

My supervisor was kind and allowed me to take my time to pack up my belongings. It took me two days to clear up my workplace, after toiling for a long period in the same jobsite. We were provided clerical help and office space, in preparation to look for another job, such as updating our resumes, and using the computer and copy machine. We were given six weeks of separation pay plus benefits.

Fortunately, with the help of a friend who is a Church parishioner, I found another job thirty days after leaving Stauffer chemical company. He hired me as a senior research chemist and as a group leader with two technicians to supervise. It was in the same field as my expertise in my previous three jobs spanning the last twenty one years. My new employer was Chevron Chemical Company, and which was located in the same area as my former employer.

This job gave me the introduction and basic knowledge of managing the work of subordinates. I worked for Chevron Company for four and a half years. The company decided to consolidate their research facilities in Texas, and lay off all its research employees. This time I had enough distress and agony from working, and eventually getting laid off from several private companies. To avoid going through any more miserable layoffs, I made a vow that I would never again work for a private company.

In my work experiences, there were noticeable and unavoidable jobsite occurrences. One can never miss the office romantic relationships between co-workers, both illicit and permitted. Though it was frowned upon, there was a boss and staff relationship, which was used as a ploy to get ahead in the company. Some relationships had chemistry, no pun intended, but some never worked out. Oftentimes, there was a sense of distrust among bench chemists for some workers who unjustly obtained preferred work assignments.

Some employees resorted to bribing superiors to get special privileges, such as being able to attend choice conferences and meetings in exciting venues or locations. Likewise, politics was always present at the worksites. It was during an era when various forms of harassment, equal opportunity and discrimination laws were not yet enforced in the workplace. Occasionally, an unexpected chemical explosion happens in a laboratory setting, where luckily no one got seriously hurt.

In the three private companies I worked for, I was able to publish scientific journals for some of the research studies and analytical methods which I developed for the respective companies of Chemagro, Shell Development and Stauffer.

After deciding and making a vow to avoid working in the private sector, I made my new goal which was either to work for the state of California, or the Federal government in Washington, D.C. Four months after I lost my job in Chevron, I was lucky and joyful to be hired by the Food and Drug Administration as a review chemist in the fall of 1990.

In 1994 I was promoted as an Expert Research Chemist with a GS-14 rating. My expertise was on Anti-malarial and Anti-parasitic drug products. In 1997, I was again deservingly promoted to Chemistry team leader, supervising the work of six Chemistry reviewers including five with doctorate degrees.

As team leader, I was responsible for prioritizing, assigning, and assuring the technical accuracy of all chemistry, manufacturing and control issues for all new drug applications submitted to the Division of Anti-Infective Drug Products, Center of New Drugs.

It was part of my responsibility to give advice, instruct and promote high morale and teamwork in my group. My work in the FDA is confidential, until the drug patent on the products I worked on has expired. There are manufacturing supplements that I have approved that are now open for the public in the Internet.

In 1998, I won the Equal Employment Opportunity (EEO) Award. The citation reads, “For outstanding accomplishments in fostering the objectives of the EEO Program by hiring minorities and encouraging their professional growth while providing excellent leadership.” I have received numerous certificates of appreciation, awards in leadership and communications, commendation for teamwork and excellence in the accomplishment of the FDA mission. I have also received several letters of appreciation from private industry for my review work.

There are many good things working as rank and file while enjoying doing one’s job individually. It is a humbling, satisfying and productive experience, if one can work in harmony with one’s immediate supervisor. Working individually develops one’s skills in goal setting and scheduling. But in general, the financial rewards are less than a person who has supervisory responsibilities.

Managing the work of others has its challenges. Moreover, it develops one’s skill in handling and developing people, and the compensation rewards and benefits are better. Due to additional duties, responsibilities and leadership, supervisory work can be more stressful than working as a subordinate. However, supervisory jobs give one more personal growth and satisfaction, based on my personal experience. My work in FDA as a team leader managing the work of six scientists had been the happiest and rewarding work experience in my career in Chemistry. You might also like:

Wednesday, January 18, 2023

Have You Heard of Environmental Assessments for New Drugs and Biologics?

No comments:

Post a Comment

Linkwithin

Write a Comment